BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1944298 · Received December 6, 2010

    Report

    Report Number
    3004209178-2010-10226
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 24, 2010
    Manufacturer
    MDTPUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT HAD A 45 MINS, PROTON DENSITY SAGITTAL, T2 TURBO SPIN ECHO SAGITTAL, T1 SPIN ECHO CORONAL MAGNETIC RESONANCE IMAGING STUDY OF HIS HEAD FOR TEMPOROMANDIBULAR JOINT PAIN. AFTERWARD THE IMPLANTABLE NEUROSTIMULATOR WAS UNRESPONSIVE TO TELEMETRY ATTEMPTS BY THE PT PROGRAMMER AND RECHARGER. THE ANTENNA LOCATE FEATURE OF THE PT PROGRAMMER DID NOT CAUSE A POWER ON RESET OF THE IMPLANTABLE NEUROSTIMULATOR. THE STIMULATION STATUS PRIOR TO THE SCAN WAS UNK. THE PT BELIEVED THE DEVICE TO BE ON DURING THE SCAN, BUT WASN'T ABLE TO CONFIRM THAT. THE IMPLANTABLE NEUROSTIMULATOR WAS IMPLANTED IN THE ABDOMEN; THE LEAD WAS LOCATED AT APPROX T8. THE STUDY DURATION WAS 45 MINS WITH PRIMARY MAGNET STRENGTH OF 1.5 TESLA. THE CONFIGURATION WAS HORIZONTAL, CLOSED BORE. THE PT WAS IN CONTACT WITH HIS HCP AND THE FIELD REPS. THE NEUROSTIMULATOR REMAINED UNRESPONSIVE AFTER PHYSICIAN MODE RECHARGES WERE DONE. THE HCP WAS DISCUSSING REPLACING THE DEVICE. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDTPUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR EXTENSION: MODEL 37081, LOT# NJB072332V| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA136076N| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB07331V| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE140101N| LEAD: MODEL 39565-30, LOT# V418058015| IMPLANTED: