BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 8876343 · Received August 8, 2019

    Report

    Report Number
    3004209178-2019-15200
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Date of Event
    July 11, 2019
    Report Date
    August 8, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37761, SERIAL#: (B)(4), PRODUCT TYPE: RECHARGER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 37761, SERIAL/LOT #: (B)(4). (B)(4). ANALYSIS FOR THE DESKTOP CHARGER ((B)(4)) REVEALED THAT THEIR CONNECTOR PINS WERE BROKEN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER ABOUT AN IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANTED FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT'S RECHARGER WAS NOT CHARGING, THE METAL PIECE BROKE OFF AND WAS STUCK IN THE RECHARGER. THE STATED HE CALLED ON THURSDAY AND RECEIVED A BELT WHICH WAS INCORRECT AND PATIENT WAS IN PAIN BECAUSE SHE NEEDED TO CHARGE HER IMPLANT. THEY STATED THIS WAS NOT THE FIRST THE METAL PIECE BROKE AND WOULD LIKE TO KNOW IF THEY COULD GET OR BUY AN EXTRA DESKTOP CHARGER CORD. THEY REVIEWED THEY CANNOT SENT OUT TWO DTCS AND CANNOT SELL JUST DTC CORD. NO OUT OF BOX FAILURE WAS REPORTED. NO FURTHER ALLEGATIONS/COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668747 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR