BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1133157 · Received August 22, 2008

    Report

    Report Number
    3004209178-2008-05166
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    June 1, 2008
    Report Date
    July 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT L4-5 SPINAL FUSION SURGERY. AFTER SURGERY THE SURGEON TOLD THE PATIENT ONE OF THE LEADS HAD BEEN CLIPPED SO THE SURGEON CUT THE LEAD AND REMOVED IT, LEAVING THE OTHER LEAD IN PLACE. IT WAS ALSO REPORTED THAT ABOUT A MONTH LATER THE PATIENT RECHARGED FOR FOUR HOURS, BUT WAS ONLY ABOUT TO GET THE BATTER UP TO 50%. THE PATIENT TURNED THE STIMULATION ON BRIEFLY THE NEXT DAY TO SEE IT WAS WORKING. THE PATIENT HAD STIMULATION IN HIS LOWER LEG AND HIPS. THE PATIENT WAS SEEN FOR INTERROGATION AND REPROGRAMMING. THE BATTERY WAS SHOWING HALF FULL. IMPEDANCE CHECK SHOWED 0-7 <3600, 8-15 >3600 (MOST LOGICALLY THIS IS THE LEAD THAT WAS CUT). PATIENT HAD STIMULATION IN HIS LEGS. THE PATIENT WAS REPROGRAMMED TO GET STIMULATION INTO HIS HIPS. THE PATIENT USED PATIENT PROGRAMMER TO TURN STIMULATION ON THEN STOOD UP AND STIMULATION WENT OFF. SYNCHRONIZED WITH PATIENT PROGRAMMER, INDICATED BATTERY WAS EMPTY. INTERROGATED WITH THE CLINICIAN PROGRAMMER AND VERIFIED THE BATTERY WAS EMPTY. CONCLUDED BATTERY WAS DAMAGED AS WELL AS LEAD. PATIENT WAS SCHEDULED FOR FOLLOW-UP WITH THE NEUROSURGEON. NO PATIENT TREATMENT OR OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HEALTHCARE PROVIDER, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 47 YR IMPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3777| EXPLANTED:| LEAD: MODEL 3777