BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK SPINAL CORD STIMULATOR

    MDR report key: 1890184 · Received October 22, 2010

    Report

    Report Number
    3007566237-2010-08268
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 27, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS IN A MOTOR VEHICLE ACCIDENT AND HE UNDERWENT A FULL BODY MRI SCAN. THE COMPANY REP WAS CALLED TO EVALUATE THE SYSTEMS AS A RESULT OF THAT EVENT. THEY NEEDED TO PROVIDE ALL OF THE INFO AND DETAILS SPECIFIC TO THAT BECAUSE HE HAD THREE DIFFERENT STIMULATION SYSTEMS. THE PT WAS IN INTENSIVE CARE FOR 6 TO 8 DAYS. THE PT WAS UNCONSCIOUS/COMA AND ON A VENTILATOR. THERE WAS NO RESPONSE AT ALL FROM PT. THE PT WAS HAVING SHOULDER TWITCHING AND THE HOSP STAFF THOUGHT EITHER HIS IMPLANTED SYSTEMS WERE TURNED ON OR THE TWITCHING WAS FROM SPASMS. THE REP COULD NOT COMMUNICATE WITH ANY OF THE THREE SYSTEMS AND HAD NO IDEA OF THE DEVICE STATUSES SINCE HE COULD NOT INTERROGATE THE DEVICES OR COMMUNICATE WITH THE PT. THE REP HAD NO ADDITIONAL OR CURRENT F/U STATUS FOR THE PT. PLEASE REFER TO MFR REPORT # 3007566237-2010-08265 AND MFR REPORT # 3007566237-2010-08269.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT #: UNK| IMPLANTABLE NEURO STIMULATOR: MODEL 37712,| LOT #: UNK| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTABLE PULSE GENERATOR: MODEL IPGNEURO,| EXPLANTED: