BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1071631 · Received July 9, 2008

    Report

    Report Number
    3004209178-2008-03866
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 8, 2008
    Report Date
    June 9, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD A CHANGE IN BODY MASS AND STARTED YOGA. A WEEK LATER, SHE NOTICED 'INTERMITTENCY'. TWO WEEKS AFTER THE BATTERY RAN OUT. THE PATIENT FELT NO STIMULATION WHEN THE DEVICE WAS TURNED ON. THE PATIENT TRIED TO RECHARGE FOR 3-4 HOURS. THE PATIENT RECHARGER AND PROGRAMMER WOULD NOT ESTABLISH COMMUNICATION WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT WAS NOT ABLE TO USE THE RECHARGER BELT OR SPACERS. THE PATIENT DIDN'T HAVE AN HCP TO MANAGE HER DEVICE. FIELD STAFF WERE CONTACTED ON HER BEHALF. THE PATIENT HADN'T RECHARGE HER DEVICE FOR 2.5 MONTHS. THE PATIENT WAS SEEN IN CLINIC SEVERAL DAYS AFTER THE ORIGINAL COMPLAINT. ERROR CODE 591 WAS SEEN ON THE PATIENT PROGRAMMER. A PHYSICIAN MODE RECHARGE WAS ATTEMPTED TWICE, BUT DID NOT FIX THE TELEMETRY PROBLEM. THE DEVICE COULD NOT BE INTERROGATED WITH THE PATIENT OR PHYSICIAN PROGRAMMER. THE PATIENT WAS SEEN IN CLINIC AGAIN APPROXIMATELY 2 WEEKS LATER AND THE MANUFACTURER'S REPRESENTATIVE WAS UNABLE TO PERFORM A PHYSICIAN MODE RECHARGE AFTER 2 HOURS OF TROUBLESHOOTING. IT WAS UNKNOWN IF THE BATTERY WAS OVERDISCHARGED. THE INS WAS UNRESPONSIVE TO TELEMETRY ATTEMPTS BY THE PHYSICIAN PROGRAMMER, THE PATIENT PROGRAMMER AND RECHARGER. THE DEVICE WAS REPLACED.

    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 RECHARGER MODEL 37752| EXPLANTED| EXTENSION MODEL 37082| PROGRAMMER MODEL 37742| LEAD MODEL 3998| EXPLANTED