BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1070191 · Received July 3, 2008

    Report

    Report Number
    3004209178-2008-03759
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    January 1, 2008
    Report Date
    June 3, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED TWO PAST OVERDISCHARGE EPISODES. A THIRD OVERDISCHARGE OCCURRED APPROXIMATELY THREE WEEKS AGO. IT WAS ALSO REPORTED THAT THE PT CHARGES MORE THAN EXPECTED AND THE RECHARGE INTERVAL DID NOT APPEAR TO BE APPROPRIATE. THE PT WOULD RECHARGE AT 8 BARS FOR ABOUT 7 HOURS EACH DAY. IT WAS REPORTED THAT AFTER FULL CHARGING, THE STIMULATION WOULD ONLY LAST FOR ABOUT 3 HOURS. AFTER THIS TIME, WHEN THE STIMULATOR WAS CHECKED WITH THE PT PROGRAMMER, IT INDICATED THAT THE BATTERY NEEDED TO BE CHARGED AGAIN. THE PT STATUS WAS REPORTED AS FAIR. NO PATIENT SYMPTOMS, TREATMENT, OR OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HEALTH CARE 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 RECHARGABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention RECHARGER: MODEL 37752| PROGRAMMER: MODEL 37742| EXPLANTED:| LEAD: MODEL 3487A