BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3132684 · Received May 29, 2013

    Report

    Report Number
    3007566237-2013-01768
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708140, SERIAL# (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 8840, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE CAUSE OF THE HIGH IMPEDANCES WAS NOT DETERMINED ALTHOUGH IT WAS BELIEVED IT WAS ATTRIBUTED TO THE EXTENSION COMPONENT. NO MALFUNCTIONS WERE NOTED DURING THE SURGICAL (¿REVISION¿) PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE TO IMPLANT THE IMPLANTABLE NEUROSTIMULATOR (INS), HIGH IMPEDANCES WERE MEASURED USING THE CLINICIAN PROGRAMMER UNIT. THE EXTENSION COMPONENT OF THE SYSTEM THEN WAS REPLACED AND IMPEDANCES MEASUREMENTS WERE THEN REPORTED AS NORMAL. THE PROCEDURE WAS THEN REPORTED AS ¿ENDED SUCCESSFULLY¿ AND NOTED THAT THE DEVICE WORKED NORMALLY DURING ADJUSTMENT. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS NOTED THAT THE HOSPITAL STAFF DISCARDED THE EXTENSION COMPONENT IN QUESTION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234700 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR