BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3790253 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-08503
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    February 1, 2014
    Report Date
    April 11, 2014
    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 3778-45, SERIAL# (B)(4), PRODUCT TYPE LEAD; PRODUCT ID 3708120, SERIAL# (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A SHOCKING/JOLTING SENSATION. IT WAS REPORTED THE SHOCKING FEELING WAS DOWN BOTH LEGS AND IN THE LOWER BACK. IT WAS NOTED THE IMPLANTABLE NEUROSTIMULATOR (INS) KEEPS TURNING ITSELF OFF AND THAT THE PATIENT WAS CHARGING MORE THAN EXPECTED. IT WAS REPORTED THE INS IS ¿GETTING LOWER FASTER¿ AND THEY NOW RECHARGE EVERY WEEK WHEN THEY USED TO CHARGE EVER 2-3 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266783 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 00052 YR