BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1890209 · Received October 22, 2010

    Report

    Report Number
    3004209178-2010-08274
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 28, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S DEVICE WAS "MISFIRING" AFTER AN MRI. IT WAS STATED THE PT WAS IN A MOTOR VEHICLE ACCIDENT AND HAD MRI OF HIS SPINE. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT # L35573| IMPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA129215N| EXPLANTED:| IMPLANTED:| RECEIVER: MODEL 3272-66, LOT # NBR001487N| EXPLANTED:| RECEIVER: MODEL 3272, LOT # NBR001544N| EXPLANTED:| IMPLANTED:| TRANSMITTER: MODEL 3210, LOT # NBU001690P| LEAD: MODEL 3777, LOT # V166098027| EXPLANTED:| IMPLANTED:| IMPLANTED:| TRANSMITTER: MODEL 3210, LOT # NBU001271P| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT # L36142| LEAD: MODEL 3777, LOT # V239005026| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE131091N