BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4121302 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17789
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EVER SINCE IMPLANT WHENEVER THE PATIENT GOT WATER ON HER ARM OR HANDS SHE GOT A STRANGE FEELING LIKE AN ¿ELECTRICAL SHOCK (ALMOST)¿. THE PATIENT HAD A CERVICAL IMPLANT FOR REFLEX SYMPATHETIC DYSTROPHY (RSD) OF THE HAND. THE THERAPY WAS WORKING QUITE WELL FOR THE PATIENT¿S PAIN. THIS WAS A NEW SYMPTOM SINCE IMPLANT. THE PATIENT FELT THE NEED TO TURN THE IMPLANTABLE NEUROSTIMULATOR (INS) OFF EVERY TIME SHE WASHED HER HANDS OR GOT WET. FIVE DAYS LATER ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY FOR HER PAIN. THE ISSUE WITH THE WATER CAUSING SHOCKING SENSATION HAS NOT BEEN EXPLAINED. ALL IMPEDANCES WERE NORMAL AND PATIENT WAS GETTING GOOD COVERAGE OF PAINFUL AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601926 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR