BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3481805 · Received November 21, 2013

    Report

    Report Number
    3004209178-2013-21214
    Event Type
    Malfunction
    Date Received
    November 21, 2013
    Report Date
    November 5, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER. PRODUCT ID: 377860, LOT# V020591, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S DEVICE HAS REACHED END OF LIFE (EOL). IT WAS NOTED THE PATIENT HAS AN APPOINTMENT ON (B)(6) 2013 TO MEET WITH THEIR HEALTH CARE PROVIDER. IT WAS NOTED THE PATIENT INQUIRED ABOUT A NEW IMPLANTABLE NEUROSTIMULATOR RECHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606711 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 Male