BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 2833666 · Received November 12, 2012

    Report

    Report Number
    1627487-2012-12486
    Event Type
    Injury
    Date Received
    November 12, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 19, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT #1627487-2012-12487. THE PT REPORTED EXPERIENCING SHOCKING AT THE LEAD WHILE STIMULATION WAS ON. THE PT ALSO REPORTED, THE PROGRAMMER DISPLAYED AN ERROR CODE FOR A STUCK BUTTON AND SUBSEQUENTLY COULD NOT BE TURNED ON. THE PT PUT NEW BATTERIES IN THE DEVICE BUT IT DID NOT RESOLVE THE ISSUE. A NEW PROGRAMMER WAS SENT TO THE PT. F/U DETERMINED THE NEW PROGRAMMER WAS SENT TO THE PT. F/U DETERMINED THE NEW PROGRAMMER WOULD NOT POWER ON. REPORTEDLY THE PT WILL TRY NEW BATTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3219 3636013

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3716