Events

Rappel de Device Recall 8870 Software Application Card Version AAA 02

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
    29849
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1334-04
  • Date de mise en oeuvre de l'événement
    2004-08-24
  • Date de publication de l'événement
    2004-09-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-12-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34649
  • 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
    Pump, Infusion, Implanted, Programmable - Product Code LKK
  • Cause
    With the model 8870 software application card versions aaa 02, bbb 04, bbc 02, and bbd 01, which is used in conjunction with the model 8840 n'vision clinician programmer, users may have mistakenly entered a periodic bolus interval into the minutes field, rather than the hours field, resulting in drug overdoses. this issue is limited to programming the synchromed and synchromed el pumps.
  • Action
    Letters were distributed 8/24/2004 utilizing a courier with signed receipt upon delivery. The letters were signed for upon receipt at the consignee address, and the contents of the letter included a response form which can be faxed or mailed back to Medtronic. If any letters are returned as 'undeliverable', attempts will be made to telephone these consignees. A press release was issued on September 22, 2004 by Medtronic Inc. for all Version AAA 02 Model 8870 software application cards in the U.S.

Device

Device Recall 8870 Software Application Card Version AAA 02
  • Modèle / numéro de série
    Software Version AAA 02, BBB 04, BBC 02, and BBD 01
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    These cards were distributed primarily in the USA, but also to countries in Europe, Middle East and Africa, Canada, Australia, Hong Kong, Latin America and Japan.
  • Description du dispositif
    8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N''Vision Clinician Programmer.
  • 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