Events

Rappel de Device Recall VNS Therapy Programmer, Model 3000 v1.0 System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Cyberonics, Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    80062
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2255-2018
  • Date de mise en oeuvre de l'événement
    2017-11-13
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164316
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Stimulator, autonomic nerve, implanted (depression) - Product Code MUZ
  • Cause
    Certain model 3000 programming events can result in miscalculation of parameters stored in the models 103, 104, 105, and 106 generators. during these programming events, the miscalculations can lead to: " delivery of more stimulation than intended, resulting in painful stimulation or other common side effects (model 106 only); " no stimulation in the case of device disablement (burst watchdog timeout), resulting in no therapy to the patient (model 106 only); " delivery of less stimulation than intended, resulting in therapeutic settings not being achieved within device specification (models 103, 104, 105, or 106); and/or " delays or absence of the 75% and 50% battery life indicators displayed by the programming software (models 103, 104, 105, or 106).
  • Action
    On November 13, 2017 LivaNva sent letters to all the doctor and surgeons that use this device. "Dear Doctor: This notification describes an issue identified with the VNS Therapy ¿ Programmer, Model 3000 version 1.0 which may impact patients implanted with Models 103, 104, 105 or 106 VNS Therapy generators. This issue does not affect Model 1000 SenTiva or Model 102/102R generators. What is the Issue? Certain programming events performed with a Model 3000 Programmer on a Model 103, 104, 105 or 106 VNS Therapy generator can result in a miscalculation of some parameters stored in the generator, which could lead to: " Output current delivered being different than that programmed; " Device disablement; and/or " Errors in the 75% and 50% battery life indicators. The actual battery life and battery function are not affected by this issue. Risk to Health This issue presents the following risks: " Delivery of more stimulation than intended, resulting in painful stimulation or other common side effects 1 (Model 106 only); " No stimulation in the case of device disablement, resulting in no therapy to the patient (Model 106 only); " Delivery of less stimulation than intended, resulting in therapeutic settings not being achieved (Models 103, 104, 105 or 106) ; or " Sudden decrease from 100% to 25% battery life indicator, though the actual battery life and battery function are not affected (Models 103, 104, 105). Which Patients are Potentially Impacted? Any patient with a Model 103, 104, 105 or 106 generator that has been programmed using a Model 3000 programmer may be affected by this issue. Your LivaNova representative will collect data from your Model 3000 programmer to identify which patients are impacted by this notice. Actions to be taken by the Physician 1. Stop using the Model 3000 programmer to program Model 103, 104, 105 or 106 generators. You shall continue using the Model 3000 programmer with Model 1000 SenTiva generators and may continue to use it wi

Device

Device Recall VNS Therapy Programmer, Model 3000 v1.0 System
  • Modèle / numéro de série
    Serial Numbers: FMT77F2, FKR57F2, FCR77F2, CJR77F2, BNT77F2, BNS77F2, 7XR77F2, 7XP57F2, 79R77F2, 90S77F2, 97Q57F2, 6NT77F2, 9GP57F2, 6KQ57F2,  B7Q57F2, 57P57F2, 55T77F2, J6R57F2, HWR77F2, 1G7G1F2, 1JR57F2,  9XP57F2, 4LR77F2, 4GT77F2, 4GR57F2, 2DT77F2, G2S77F2, FVQ77F2,  G5T77F2, FDQ57F2, F5R57F2, F2R57F2, F1Q57F2, GHS77F2, DVR77F2,  DNP57F2, DMYB7F2, DJS77F2, D1R57F2, CVQ57F2, H4R57F2, 85S77F2,  89T77F2, 8LYB7F2, 97YB7F2, 6MQ57F2, 6CQ57F2, 5HS77F2, JLQ57F2,  JGS77F2, 11R57F2, 1TQ57F2, 1YR77F2, 2DR77F2FXP57F2 , FTR77F2, FPQ57F2, FNQ57F2, FLYB7F2, FFP57F2, GGT77F2, GSQ57F2, CMS77F2, H1R77F2, H3R57F2, 7LS77F2, 9KR57F2, 9NS77F2, 65R57F2, B8R77F2,  B9T77F2, 5D0C7F2, B9YB7F2, BJR57F2, JCQ57F2, J9YB7F2, HMYB7F2, CDQ57F2, FXQ57F2, G5S77F2, G3R77F2, FRQ57F2, G7YB7F2, FLS77F2, G90C7F2, FGR77F2, FFT77F2, G9Q57F2, FCT77F2, G9R57F2, F9YB7F2,  F9S77F2, F8T77F2, GDQ57F2, F7R57F2, F4T77F2, DWR77F2, DTR77F2,  DSQ57F2, GMQ57F2, DLS77F2, DH0C7F2, DGS77F2, DGP57F2, GZR77F2, D1Q57F2, CSQ57F2, CLS77F2, C9YB7F2, C70C7F2, H1R57F2, C1R77F2,  7MS77F2, 78YB7F2, 9SQ57F2, 5VQ57F2, 5RQ57F2, B60C7F2, 5NQ57F2, 5MR77F2, 5KS77F2, B8T77F2, BHP57F2, BJR77F2, 4JS77F2, H4T77F2,  JZQ57F2, JMS77F2, JMQ57F2, JG0C7F2, JBQ57F2, J8T77F2HZQ57F2, J7R57F2, HVR77F2, HTP57F2, HNS77F2, HMQ57F2, HKQ57F2, H7S77F2,  D3R57F2, 1CQ57F2, 1HT77F2, 1MYB7F2, 2CP57F2, 2LYB7F2, CLYB7F2,  CMYB7F2, B4R77F2, B2S77F2, B0R57F2, 9QS77F2, D8Q57F2, 960C7F2, 95T77F2, 8JR77F2, 8HR57F2, BXP57F2, BWR77F2, BTQ77F2, C8YB7F2,  C60C7F2, BLR77F2, BLQ57F2, BGR77F2, BGP57F2, CHQ57F2, CKR57F2, CPP57F2, CSR77F2, CTQ77F2, CXR77F2, 9MS77F2, 9JR77F2, 9DQ57F2, D7S77F2, 94T77F2, 8PQ57F2, BWQ77F2, BSR77F2, BNQ57F2, C9R57F2, C8R57F2, C5R57F2, CF0C7F2, C3R57F2, CFP57F2, BDT77F2, B9S77F2, B5R57F2, CPQ57F2, B4R57F2, D2R57F2, 9KQ57F2, D5R77F2, 9F0C7F2, 980C7F2, D9YB7F2, 8WR77F2, DB0C7F2, 9P7G1F2, D3S77F2, D6R57F2, D7R57F2, 9CR77F2, 9G0C7F2, 96R57F2, DFP57F2, C0S77F2, BN7G1F2, BQ7G1F2, C8S77F2, CB0C7F2, CCR77F2, BHR57F2, CHP57F2, BCR77F2, BBR77F2, BB0C7F2, B90C7F2, B70C7F2, B2R57F2, 9VP57F2, 9TQ57F2, 9GR57F2, 9FP57F2, 9BS77F298R57F2 ,D80C7F2, 970C7F2, D8YB7F2, 95R77F2, 8YR77F2, C1R57F2, C80C7F2, C3R77F2, CNS77F2, 9VQ77F2, D4T77F2, 9DR77F2, 91R57F2, 8VQ77F2, 8RQ57F2, DBS77F2, 8JS77F2, C0R57F2, BTR77F2, BMYB7F2, BKR77F2, BBP57F2 and B8S77F2
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    AL, CA, CO, DE, FL, GA, ID, IL, IN, ME, MO, MS, NC, NJ, NY, PA, TN, TN, TX, UT, WA and WI
  • Description du dispositif
    VNS Therapy Programmer, Model 3000, v1.0 System
  • Manufacturer
    Cyberonics, Inc

Manufacturer

Cyberonics, Inc
  • Adresse du fabricant
    Cyberonics, Inc, 100 Cyberonics Blvd, Houston TX 77058-2069
  • Société-mère du fabricant (2017)
    LivaNova PLC
  • Source
    USFDA