BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENESIS 8-CHANNEL RECHARGEABLE IPG

    MDR report key: 2214124 · Received July 12, 2011

    Report

    Report Number
    1627487-2011-03266
    Event Type
    Other
    Date Received
    July 12, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 A SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PT WAS WITHOUT STIMULATION AND THE IPG WAS SHOWING 'LOW IPG' ERROR. WHEN THE FLAG WAS CLEARED, THE PROGRAMMER SHOWED VARIOUS ERROR CODES. ATTEMPTS TO FOLLOW UP WITH THE PT HAVE BEEN UNSUCCESSFUL. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS 8-CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION 3608 3213646

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3224