BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESIS DUAL HEADER IPG

    MDR report key: 2043152 · Received February 24, 2011

    Report

    Report Number
    1627487-2011-01161
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 AND TWO PERCUTANEOUS LEADS, ON (B)(6) 2009. IT WAS REPORTED THAT THE PT LOST STIMULATION. THE PT'S PROGRAMMER DISPLAYED A CONNECT WAND ERROR, AND IT WAS REPORTED THAT HE WAS UNABLE TO USE THE PROGRAMMER. A REPLACEMENT PROGRAMMER WAS SENT TO THE PT; HOWEVER, IT IS CURRENTLY UNDETERMINED WHETHER THE REPLACEMENT DEVICE RESOLVED THE ISSUE. NO FURTHER INFO IS AVAILABLE AT THIS TIME. THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE AS SIMILAR ALLEGED EVENTS HAVE OCCASIONALLY RESULTED IN THE EXPLANT OF THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS DUAL HEADER IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3643 116036

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention