BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1132639 · Received August 22, 2008

    Report

    Report Number
    3004209178-2008-05160
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INS AND EXTENSIONS WERE RETURNED FOR ANALYSIS. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEUROSTIMULATOR (INS) WAS UNRESPONSIVE TO TELEMETRY ATTEMPTS BY THE PT PROGRAMMER, RECHARGER, AND PHYSICIAN PROGRAMMER. THIS IS THE SECOND INS WHERE THIS HAS HAPPENED WITH THIS PT. THE PHYSICIAN KEPT GETTING A 591 ERROR CODE, SUGGESTING ELECTROMAGNETIC INTERFERENCE (EMI). THE PHYSICIAN ATTEMPTED TO REMOVE THE PT FROM ANY ENVIRONMENT EMI, FIRST BY GOING TO THE PARKING LOT, THEN DRIVING OUT OF TOWN TO A LOCATION CLEAR OF ANY SOURCES OF EMI. THE 591 ERRORS CONTINUED. THE PHYSICIAN ATTEMPTED TO SYNC THE DEVICE WITH THE PROGRAMMER AWAY FROM THE PT AND GOT A 590 ERROR CODE. THE PHYSICIAN ALSO TRIED TO INTERROGATE THE PT'S INS USING A NEWER PT PROGRAMMER, BUT COULD NOT COMMUNICATE WITH THE INS. DUE TO THE NON-RESPONSIVE INS, THE PT WAS UNABLE TO TURN HIS STIMULATOR OFF. THE PT HAD HIGH SETTINGS WHILE WORKING. TYPICALLY, THE PT CANNOT SIT OR LAY DOWN WITH HIS "WORK SETTINGS". THE STIMULATOR WAS IN THESE SETTINGS WHEN IT BECAME UNRESPONSIVE. THE PT WORKS AS A WELDER. THE PT UNDERWENT SURGERY AND THE INS WAS REPLACED WITH A NON-RECHARGEABLE INS. THE LEADS AND EXTENSIONS WERE ALSO REPLACED. THE PT RECOVERED WITHOUT SEQUELA. REFERENCE MFR REPORT #3004209178-2008-02692.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTENSION MODEL 37083| LEAD MODEL 3888| EXPLANTED| EXPLANTED| LEAD MODEL 3888| ACCESSORY MODEL 37752| PROGRAMMER MODEL 37742| EXPLANTED| EXPLANTED| EXTENSION MODEL 37083