BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3089784 · Received May 2, 2013

    Report

    Report Number
    3004209178-2013-07216
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 377860, LOT# V001918, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 377860, LOT# V001918, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S LEAD MOVED ABOUT A YEAR AGO. THE DEVICE DID NOT WORK SINCE THE WIRES CROSSED. SHE WOULD GET 'ZAPPED' TO THE POINT THAT HER LEG WOULD GO OUT. HER BATTERY HAS DEPLETED SO SHE NO LONGER GETS 'ZAPPED.' HER HEALTH CARE PROVIDER RECOMMENDED THAT A SURGICAL LEAD BE PLACED. IT WAS PAINFUL UNDER THE INS SITE AT HER HIP FOR SEVERAL MONTHS TO THE POINT THAT SHE COULD HARDLY WALK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191240 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1