BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3161610 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10123
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3 7754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT COULD NOT GET THE IMPLANTABLE NEUROSTIMULATOR (INS) TO SYNC WITH THE PATIENT PROGRAMMER. IT WAS DETERMINED THE PATIENT NEEDED TO CHARGE THE INS. IT WAS REPORTED THE INS WAS PLACED IN SUCH A ¿FUNKY¿ PLACE THAT THE PATIENT NEEDED HELP WITH RECHARGING. THE INS WAS PLACED ON HIS BELT LINE AND WAS ¿TOO HIGH.¿ THE INS WAS REPORTED TO HAVE BEEN MOVING AND WAS TILTED. THE NIGHT PRIOR THE RECHARGER HAD SHOWN A ¿STRANGE SCREEN¿ AND THE INS HAD STOPPED CHARGING. IT WAS NOTED AS A COUPLING PROBLEM. PATIENT EDUCATION RESOLVED THE REPORTED ISSUE. IT WAS LATER REPORTED THAT THE PATIENT RECEIVED ASSISTANCE AND NO LONGER HAD CONCERNS WITH THEIR DEVICE OR THERAPY. THE PATIENT¿S CONCERNS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261845 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1