Events

Rappel de Device Recall Medtronic Restore Neurostimulator

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 Medtronic Inc, Neurological & Spinal Division.

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
    34225
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0905-06
  • Date de mise en oeuvre de l'événement
    2005-11-22
  • Date de publication de l'événement
    2006-05-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-12-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43301
  • 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, Spinal-Cord, Implanted (Pain Relief) - Product Code GZB
  • Cause
    A limited number of model 37711 restore neurostimulators have an incorrect internal memory parameter that causes the device to indicate it is fully recharged when it may only be 80% to 90% recharged. this anomaly does not affect patient safety. this anomoly can be corrected by reprogramming the restore neurostimulator using specific software.
  • Action
    A 'Customer Communication' letter was sent to Medtronic field personnel to hand-carry into the affected accounts; customer contact began on 11/22/2005. The letter explains the patients implanted with these devices likely will only be able to recharge their neurostimulator to about 80-90% of a full charge. This anomaly does not affect device safety or effectiveness but Medtronic will re-program them upon request for customer satisfaction. The letter will be followed by scheduled on-site visit to reset the internal memory parameter of the neurostimulator.

Device

Device Recall Medtronic Restore Neurostimulator
  • Modèle / numéro de série
    NJH701951H thru NJH801963H, NJH701965H, NJH701967H thru NJH701969H, NJH701971H thru NJH701975H, NJH701978H thru NJH701986H, NJH702007H, NJH702008H, NJH702028H, NJH702029H, NJH702032H, NJH702033H, NJH702035H, NJH702036H, NJH702038H, NJH702039H, NJH702044H, NJH702045H, NJH702144H, NJH702145H, NJH702146H, NJH702150H, NJH702152H, NJH702153H, NJH702157H, NJH702158H, NJH702159H, NJH702160H, NJH702162H, NJH702163H, NJH702164H, NJH702166H, NJH702168H, NJH702169H, NJH702171H thru NJH702175H, NJH702183H, NJH702184H, NJH702213H, NJH702215H, NJH702216H, NJH702263H, NJH702324H, NJH702425H, NJH702427H, NJH702428H, NJH702429H, NJH702434H, NJH702436H, NJH702438H, NJH702439H, NJH702441H, NJH702443H, NJH702447H, NJH702451H, NJH702452H, NJH702455H, NJH702458H, NJH702487H, NJH702765H, NJH702772H, NJH702809H, NJH702834H, NJH702852, NJH702862H, NJH702863H, NJH702919H, NJH702980, NJH702982H, NJH702990H, NJH702993H, NJH702999H, NJH703001H
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide (AZ, CA, FL, ID, IL, IN, KS, KY, MA, MD, MI, MO, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, and WI).
  • Description du dispositif
    Medtronic Model 37711 Restore Neurostimulator. The Restore Neurostimulator is an implanted, rechargeable neurostimulator which provides pain management therapy.
  • Manufacturer
    Medtronic Inc, Neurological & Spinal Division

Manufacturer

Medtronic Inc, Neurological & Spinal Division
  • Adresse du fabricant
    Medtronic Inc, Neurological & Spinal Division, 800 53rd Ave Ne, Columbia Heights MN 55421-1241
  • Source
    USFDA