BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESIS IMPLANTABLE PULSE GENERATOR

    MDR report key: 2142098 · Received May 25, 2011

    Report

    Report Number
    1627487-2011-02666
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE IPG WAS NOT PROVIDED; THEREFORE, NO MFG OR EXPIRATION DATE CAN BE DETERMINED. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2002. IT WAS REPORTED THE PT IS NOT RECEIVING ANY STIMULATION FROM THE IPG. IN ADDITION, THE PT CANNOT ESTABLISH TELEMETRY WITH THE IPG. THE PT IS WORKING CLOSELY WITH HIS PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3186