BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 5189530 · Received October 29, 2015

    Report

    Report Number
    3004209178-2015-21859
    Event Type
    Malfunction
    Date Received
    October 29, 2015
    Date of Event
    September 13, 2015
    Report Date
    October 5, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4). ANALYSIS OF THE DESKTOP CHARGER (SERIAL # (B)(4)) FOUND THAT THE CABLE ASSEMBLY WAS DAMAGED WITH A METAL CONNECTOR BROKEN OFF AT THE END OF THE CABLE.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THEIR CHARGING CORD BROKE OFF. THE DESKTOP CHARGER ALSO HAD A BROKEN CONNECTOR PIN. THE DESKTOP CONNECTOR PIN BROKE ON (B)(6) 2015. THE PATIENT WAS SENT A REPLACEMENT DESKTOP CHARGER THE NEXT DAY SO THEY WERE ONLY WITHOUT THE USE OF THE STIMULATOR FOR ONE DAY. THE PATIENT WAS INDICATED FOR NON-MALIGNANT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718778 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR