BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 4484523 · Received February 4, 2015

    Report

    Report Number
    3004209178-2015-01749
    Event Type
    Malfunction
    Date Received
    February 4, 2015
    Report Date
    January 13, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 377875, LOT# V001924, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD (X2); PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD RANDOM, NON-REPRODUCIBLE SHOCKING SENSATIONS IN RANDOM LOCATIONS OF HER BODY. THE SHOCKING WAS IN RANDOM LOCATIONS AT RANDOM TIMES. THE PATIENT DENIED ANY TRAUMA. IMPEDANCES WERE ¿WITHIN NORMAL¿ , AND NONE SHOWED AN SHORT CIRCUIT. THE MANAGING PHYSICIAN CHECKED THE SYSTEM UNDER FLUORO AND FOUND NO ANOMALIES. THE PATIENT STATED THAT THE NORMAL STIMULATION HAD NOT CHANGED AND SHE WAS GETTING COVERAGE/STIMULATION WHERE SHE NEEDED IT. THERE HAD BEEN NO SHOCKING IN A FEW WEEKS/RECENTLY. DIAGNOSTIC TESTING INCLUDED IMPEDANCE TESTING AND X-RAYS. THE CAUSE OF ISSUE WAS NOT DETERMINED. THE EVENT OCCURRED DURING NORMAL USE. THE PRODUCT STATUS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED AND REMAINS-IN-SERVICE. THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82501 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR