BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3132320 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08257
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 4, 2013
    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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3998, LOT# V060415, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT TOOK THE PATIENT FOREVER TO CHARGE THE PREVIOUS NIGHT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LOST 100 POUNDS OF WEIGHT SINCE IMPLANTATION. IT WAS NOTED THAT THE DEVICE WAS MOVING CLOSER TO THE TAILBONE, MAKING IT UNCOMFORTABLE AND HARD TO CHARGE. THE REPORTER NOTED THAT IT TOOK THE PATIENT 6 HOURS TO COMPLETELY CHARGE THEIR DEVICE. IT WAS NOTED THE STIMULATION WAS ¿FINE.¿ ADDITIONAL INFORMATION WAS REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235316 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