BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2884473 · Received December 22, 2012

    Report

    Report Number
    3004209178-2012-12198
    Event Type
    Malfunction
    Date Received
    December 22, 2012
    Report Date
    December 4, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE TURNED ITSELF OFF AND SHE HAD NOTICED IT THREE OR FOUR TIMES. THE PATIENT HAD BEEN TAKING NOTES WHEN IT OCCURRED BECAUSE SHE WAS NOT ALWAYS 100% SURE IT WAS HAPPENING. THE PATIENT HAD ONE EXAMPLE WHERE SHE CHECKED THE PATIENT PROGRAMMER TO MAKE SURE HER IMPLANT WAS ON BEFORE BED, BUT WHEN SHE AWOKE, HER DEVICE WAS OFF. THIS PROBLEM HAD BEEN OCCURRING FOR "AT LEAST" A COUPLE WEEKS PRIOR TO THE REPORT. THERE ARE NO RELATED TRAUMAS OR FALLS AND THE PATIENT WAS NOT USING ADAPTIVE STIMULATION. THE BATTERY DEPLETION WAS ALSO REPORTED AS PREMATURE AND THAT THE CHARGE INTERVAL WAS GETTING SMALLER AND SMALLER. THE CHARGE FREQUENCY WENT FROM ONCE EVERY WEEK AND A HALF TO EVERY TWO OR THREE DAYS. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2012 REPORTED THAT PATIENT DID NOT BELIEVE SHE WAS PRESSING THE OFF BUTTON ACCIDENTLY. THE PATIENT WAS NOT AWARE OF WHEN HER DEVICE TURNED OFF; SHE JUST STARTED FEELING "ACHY." THE PATIENT'S DIARY WAS REVIEWED AND USAGE FROM (B)(6) 2012 TO (B)(6) 2012 SHOWED THE DEVICE WAS ON EVERY DAY AND NOT BEEN SHUT OFF UNTIL THE DAY OF THE REPORT. FOUR DAYS LATER IT WAS REPORTED THAT NO DIAGNOSTICS WERE PERFORMED. NO MALFUNCTIONS WERE SEEN OR DETERMINED AND NO INTERVENTIONS WERE PLANNED. THE PATIENT WAS DOING GREAT AND WAS TO KEEP A LOG REGARDING THE STIMULATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1