BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 8949777 · Received August 30, 2019

    Report

    Report Number
    3004209178-2019-16682
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Date of Event
    August 3, 2019
    Report Date
    August 30, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109506
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37761, SERIAL#: (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 37761, SERIAL/LOT #:(B)(4). EVENT DATE MONTH AND YEAR VALID. ANALYSIS OF THE DESKTOP CHARGER SERIAL #: (B)(4). FOUND THE CABLE ASSEMBLY 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 REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT THE METAL TIP (CONNECTOR PIN) BROKE OFF OF THE DESKTOP CHARGER AND THE PATIENT WAS UNABLE TO CHARGE THE IMPLANT AS THE RECHARGER WAS DEAD. THE PATIENT HAD BEEN IN PAIN FOR 48 HOURS AS THEY HAD BEEN UNABLE TO USE THEIR IMPLANT. THEY FURTHER REPORTED THAT THEY RECEIVED A REPLACEMENT DESKTOP CHARGER, BUT WHEN THEY PLUGGED IT IN IT SILVER PART WOULDN'T GO IT. IT WAS LIKE SOMETHING WAS STUCK IN THE RECHARGER AND THE RECHARGER JACK WAS LOOSE. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743888 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97712 00643169109506

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR