BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2090901 · Received April 26, 2011

    Report

    Report Number
    3004209178-2011-03112
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    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, THERE WERE HIGH IMPEDANCES. ELECTRODES 0, 3, 4, AND 7 MEASURED >40,000 OHMS. THERE WAS ALSO A POWER ON RESET CONDITION WITH DIAGNOSTIC IDENTIFIER CODE 0X400. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION 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 31 YR LEAD: MODEL 39565-30, LOT# N201879003| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA122867N| EXTENSION: MODEL 37081, LOT# NJB059656V| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB059629V| PROGRAMMER: MODEL 37743, LOT# NKE120182N| EXPLANTED: