BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5217425 · Received November 11, 2015

    Report

    Report Number
    3004209178-2015-22627
    Event Type
    Malfunction
    Date Received
    November 11, 2015
    Report Date
    October 19, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: (B)(4), PRODUCT TYPE: RECHARGER. (B)(4). ANALYSIS OF THE DESKTOP CHARGER (SERIAL # (B)(4)) FOUND A BROKEN METAL CONNECTOR. (B)(4) APPLIES TO THE INS. (B)(4) APPLIES TO THE DESKTOP CHARGER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE METAL PART OF THE DESKTOP CHARGER CONNECTOR PIN BROKE OFF. THE PLASTIC PIECE ON THE RECHARGER BELT ALSO BROKE OFF. THEY LAST CHARGED THEIR DEVICE ON (B)(6) 2015 AND NOTED THAT THEY HAD CHARGED 126 TIMES. SINCE THEY COULD NOT RECHARGE THEIR IMPLANTABLE NEUROSTIMULATOR (INS) IT HAD GONE INTO AN OVERDISCHARGED STATE. THE PATIENT WAS SENT A REPLACEMENT DESKTOP CHARGER AND RECHARGER BELT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THE PATIENT WAS INDICATED FOR SPINAL PAIN AND CHRONIC LOW BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748279 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR