BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS PULSE GENERATOR, 8-CHANNEL

    MDR report key: 2113699 · Received June 2, 2011

    Report

    Report Number
    1627487-2011-00761
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 AN SCS SYSTEM INCLUDING AN IPG ON (B)(6) 2009. IT WAS REPORTED THAT THE PT'S IPG POCKET INCISION RE-OPENED. SURGICAL INTERVENTION WAS UNDERTAKEN TO CLOSE THE INCISION AND NO SIGNS OF INFECTION WERE OBSERVED. FOLLOWING THE PROCEDURE, COMMUNICATION COULD NOT BE ESTABLISHED WITH THE PT'S IPG VIA THE PROGRAMMER. IT WAS LATER DETERMINED THAT THE IPG WAS IN SLEEP MODE. AFTER THE WAKE-UP PROTOCOL FOR THE DEVICE WAS PERFORMED, EFFECTIVE STIMULATION WAS RECAPTURED FOR THE PT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS PULSE GENERATOR, 8-CHANNEL TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3608 176081

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention IMPLANTED:| SCS LEAD: MODEL 3189