BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESIS CONVENTIONAL IPG

    MDR report key: 1993673 · Received January 6, 2011

    Report

    Report Number
    1627487-2011-01018
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT ((B)(6)) RECEIVED HER SCS SYSTEM SIX MONTHS PRIOR. THE PT REPORTED THAT THE IPG DISPLAYED "LOW BATTERY" MESSAGE FOR SEVERAL DAYS. EVEN AFTER CLEARING THE MESSAGE, IT REAPPEARED IN 24 HOURS. A REPRESENTATIVE OF SJM PERFORMED A LONGEVITY CALCULATION OF THE PATIENT'S IPG BASED ON THE PROGRAMMED PARAMETERS. IT WAS REPORTED THAT THE IPG SHOULD LAST APPROX 95 MONTHS FROM THE IMPLANT DATE AT 100% USAGE. THE MESSAGE WAS REPORTED AS MOST LIKELY RELATED TO BATTERY PASSIVATION. FOLLOW UP ON THE PT FOUND THAT THE PASSIVATION MESSAGE WAS NOT LONGER DISPLAYED. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS CONVENTIONAL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3608 28970079

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention