BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3979486 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13941
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 377760, LOT# V014129, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 377760, LOT# V014129, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S STIMULATOR WAS NOT STAYING CHARGED AND DID NOT FUNCTION LIKE IT WAS SUPPOSED TO. IT WAS NOTED THE PATIENT WAS APPROACHING NINE YEARS SINCE IMPLANT. IT WAS REPORTED THE PATIENT WAS RECHARGING FOR LONGER THAN EXPECTED. IT WAS NOTED THE PATIENT WAS UNABLE TO USE THEIR STIMULATOR AS OFTEN DUE TO THE ISSUE. IT WAS REPORTED THE PATIENT FELT AS THOUGH THEY SHOULD HAVE THEIR DEVICE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT铠STIMULATOR WAS WORKING AND APPROACHING END OF SERVICE (EOS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458599 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 00033 YR