BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1191183 · Received September 26, 2008

    Report

    Report Number
    3004209178-2008-06174
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    June 1, 2008
    Report Date
    September 8, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PRE-EXISTING PAIN SYMPTOMS. INTERROGATION REVEALED HIGH IMPEDANCE ON SOME BIPOLAR PAIRS. THE PATIENT'S STIMULATOR WAS REPROGRAMMED WITH IMPROVED COVERAGE. HIGH IMPEDANCE WAS STILL NOTED ON SOME BIPOLAR PAIRS. THE PHYSICIAN DID NOT PLAN TO DO ANY FURTHER ACTION AT THIS TIME. THE PATIENT OUTCOME WAS REPORTED AS NO INJURY.

    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 68 YR Required Intervention LEAD: MODEL 3778| EXPLANTED:| IMPLANTED: