BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 7797760 · Received August 20, 2018

    Report

    Report Number
    3004209178-2018-18635
    Event Type
    Malfunction
    Date Received
    August 20, 2018
    Report Date
    August 20, 2018
    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

    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 FAILED BACK SURGERY SYNDROME AND SPINAL PAIN. IT WAS REPORTED THE PATIENT¿S DEVICE WAS NOT WORKING, AND SHE WAS IN A LOT OF PAIN. IT WAS STATED THE PATIENT WAS UNABLE TO SYNC WITH THE INS OR CHARGED IT. PATIENT CONFIRMED SEEING THE REPOSITION ANTENNA SCREEN ON THE INS RECHARGER WHEN TRYING TO START A NORMAL CHARGING SESSION. TROUBLESHOOTING USING THE PATIENT PROGRAMMER (PP) WAS NOT POSSIBLE AS IT WOULD ONLY MOMENTARILY POWER ON BEFORE GOING DEAD AGAIN. PATIENT TRIED MULTIPLE SETS OF BATTERIES, INCLUDING ALKALINE BATTERIES THAT WERE KNOWN TO BE GOOD BATTERIES. PP POWERS OFF BEFORE PATIENT COULD SYNC WITH IT, AND THEN IT WOULD NOT POWER ON AT ALL AFTER THIS OCCURRED. IT WAS STATED THE PP POWERS UP BUT SHUT DOWN WHEN THEY PUSHED ANY BUTTONS, THEY TRIED NEW ALKALINE BATTERIES. PATIENT WOULD BE SEND A REPLACEMENT PP. NO FURTHER COMPLICATION AND NO SYMPTOMS WERE REPORTED. REFER TO (B)(4) FOR 1ST OD, (B)(4) FOR SECOND OD, (B)(4) FOR TROUBLE REACHING INS SITE, REVISION, AND (B)(4) FOR THIRD OD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640612 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1