BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 9136330 · Received September 30, 2019

    Report

    Report Number
    3004209178-2019-18670
    Event Type
    Malfunction
    Date Received
    September 30, 2019
    Date of Event
    September 6, 2019
    Report Date
    October 30, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37751 LOT# SERIAL# (B)(4) IMPLANTED: EXPLANTED: PRODUCT TYPE RECHARGER PRODUCT ID 37761 LOT# SERIAL# (B)(4) IMPLANTED: EXPLANTED: PRODUCT TYPE RECHARGER (B)(4): ANALYSIS OF THE DESKTOP CHARGER (SERIAL # (B)(4) FOUND THE CABLE ASSEMBLY CONNECTOR PIN WAS BENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37751, SERIAL#: (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37761, SERIAL#: (B)(4), PRODUCT TYPE: RECHARGER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 37761, SERIAL/LOT #: (B)(4). (B)(4). 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). IT WAS REPORTED THAT THE PATIENT HAD A HARD TIME CHARGING THE INS BECAUSE THE RECHARGER WOULDN'T TAKE A CHARGE WHEN PLUGGED INTO THE WALL. THE RECHARGER JUST SHOWED THE CHARGE THE RECHARGER BATTERY SCREEN EVEN THOUGH IT WAS PLUGGED INTO THE WALL. SINCE THEY COULDN¿T CHARGE THE INS, THEY WERE NOW IN PAIN. INITIALLY THE DESKTOP CHARGER LIGHT WASN'T ON AND THE CALLER TRIED 5 DIFFERENT OUTLETS, BUT THEY WERE ABLE TO GET THE LIGHT TO COME ON. THE RECHARGER STILL WOULDN'T TAKE A CHARGE AND THE DESKTOP CHARGER TIP LOOKED OKAY. IT WAS FURTHER REPORTED THAT THE CONTROLLER WASN'T CHARGING. THE DESKTOP CHARGER METAL PIECE WIGGLED AND THE PIN WAS LOOSE. THEY TRIED DIFFERENT OUTLETS. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930235 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR