BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2862958 · Received December 10, 2012

    Report

    Report Number
    9614453-2012-00237
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    July 24, 2012
    Report Date
    November 13, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LACK OF THERAPY AFTER A SERIOUS FALL. IT WAS STATED THAT ERROR CODE 33 APPEARED AT DEVICE INTERROGATION. THE REPORTER STATED THAT THE PATIENT FEELS SHOCKS AROUND THE DEVICE, EVEN THOUGH THE "BATTERY WAS EMPTY." IT WAS STATED THAT THE PATIENT HAD AN APPOINTMENT WITH THE SURGEON TO MAKE A DECISION. THERE WERE NO PATIENT SYMPTOMS OR INJURIES ASSOCIATED WITH THIS EVENT. THE PATIENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS UNAVAILABLE AT THE DATE OF THIS REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT X-RAYS WERE TAKEN BUT THERE WERE NO RESULTS. THE PATIENT WAS NOT RECEIVING THERAPY. IT WAS STATED THAT THE DEVICE WAS NOT SUFFICIENTLY CHARGED DURING THE IMPLANT TIME. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT EXPLANTED AND IT WAS UNKNOWN IF THE INS WAS GOING TO BE EXPLANTED. ADDITIONAL REVIEW OF INFORMATION REPORTED THAT TELEMETRY WITH THE INS WAS POSSIBLE, BUT THE PATIENT WAS UNABLE GET STIMULATION EVEN AFTER CHARGING FOR ONE HOUR. AFTER ONE HOUR THE PATIENT'S SKIN 'STARTED TO HEAT' SO THEY STOPPED CHARGING. IT WAS STATED THAT WHEN RECHARGE STARTS THE PATIENT FELT PAIN JUST ABOVE HER DEVICE. FURTHER INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 37713

    Patients

    Seq Age Sex Outcome Treatment
    1