BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3604271 · Received February 3, 2014

    Report

    Report Number
    3004209178-2014-01509
    Event Type
    Injury
    Date Received
    February 3, 2014
    Report Date
    January 28, 2014
    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
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3986A, LOT# N111032, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    NURSE CALLED BECAUSE PATIENT¿S DEVICE IS NOT WORKING. PATIENT UNABLE TO CHARGE. RETURN OF PAIN. THE CALLER REPORTS A LOSS OF THERAPEUTIC EFFECT. IT WAS LATER REPORTED THAT THE PATIENT¿S DEVICE WAS EXPLANTED DUE TO OVERDISCHARGE. THE STIMULATOR WAS EXPLANTED ON (B)(6) 2014. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY DISCHARGED AND WOULD NOT CHARGE AGAIN. PATIENT WANTED TO DONATE THE RECHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70930 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Required Intervention