BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2172372 · Received June 23, 2011

    Report

    Report Number
    3007566237-2011-04759
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING SURGERY TO REPLACE THE PT'S IMPLANTABLE NEUROSTIMULATOR DUE TO NORMAL BATTERY DEPLETION, THE NEW DEVICE'S IMPEDANCE READINGS WERE ALL GREATER THAN 10,000 OHMS. IMPEDANCE READINGS WERE RETESTED TWO MORE TIMES WITH THE SAME RESULT. BOTH SIDES OF THE PADDLE LEAD WERE TESTED WITH THE MULTI-LEAD TRAILING CABLE (MLTC), ONE AT A TIME, AND THE IMPEDANCE READINGS WERE "GOOD." THE EXTENSIONS WERE WIPED AND THE LEAD WAS RECONNECTED TO THE EXTENSIONS AND THE NEUROSTIMULATOR. IMPEDANCE READINGS WERE FOUND TO BE GREATER THAN 10,000 OHMS. IMPEDANCES WERE RETESTED TWO MORE TIMES. THE EXTENSION/LEAD WAS CONNECTED TO THE MLTC AND THE IMPEDANCE READINGS WERE "GOOD." A NEW NEUROSTIMULATOR WAS, THEN, OPENED AND USED WITH "GOOD" IMPEDANCE READINGS. NO PT'S SYMPTOMS OR INJURY WERE REPORTED. A F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC NEUROMODULATION 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR EXPLANTED:| RECHARGER: MODEL 37752, LOT# NKA012829N| PROGRAMMER: MODEL 37742, LOT# NJD016701N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC001975N| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3998, LOT# J0527051V| EXTENSION: MODEL 37083, LOT# NKC001976N