BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2244035 · Received August 24, 2011

    Report

    Report Number
    3004209178-2011-06763
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 25, 2011
    Report Date
    December 21, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    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). THE STIMULATOR HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF IMPLANTABLE NEUROSTIMULATOR (INS) MODEL 37712, SERIAL # (B)(4) DETERMINED NO ANOMALY WAS FOUND. GOOD, STABLE OUTPUT WAS FOUND ON ALL ELECTRODES REFERENCED TO ONE ELECTRODE. THE OUTPUT MATCHED THE PROGRAMMED SETTINGS. THERE WAS GOOD STABLE OUTPUT ON EACH ELECTRODE PAIR REFERENCED TO THE #0 ELECTRODE USING THE PATIENT'S LEAD CONFIGURATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE ABNORMAL IMPEDANCES AT IMPLANT. THE LEADS AND EXTENSIONS WERE DISCONNECTED AND RECONNECTED TO THE STIMULATOR, AND MINERAL OIL WAS INJECTED INTO THE STIMULATOR PORTS. THE ABNORMAL IMPEDANCE DID NOT RESOLVE. THE STIMULATOR WAS REPLACED, AND IMPEDANCES WERE WITHIN NORMAL RANGE. THERE WAS NO PT INJURY, AND THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR EXTENSION: MODEL 37083, LOT # NKC003688V| EXTENSION: MODEL 37083, LOT # NKC004714V| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3986A, LOT # N272726| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3986A, LOT # N280992