Events

Recall of Device Recall 8870 Software Application Card Version AAA 02

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Inc, Neurological & Spinal Division.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    29849
  • Event Risk Class
    Class 1
  • Event Number
    Z-1334-04
  • Event Initiated Date
    2004-08-24
  • Event Date Posted
    2004-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34649
  • Notes / Alerts
    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.
  • Extra notes in the data
    Pump, Infusion, Implanted, Programmable - Product Code LKK
  • Reason
    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
  • Model / Serial
    Software Version AAA 02, BBB 04, BBC 02, and BBD 01
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    3
  • Implanted device?
    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.
  • Product Description
    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
  • Manufacturer Address
    Medtronic Inc, Neurological & Spinal Division, 800 53rd Ave Ne, Columbia Heights MN 55421-1241
  • Source
    USFDA