BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2061820 · Received March 30, 2011

    Report

    Report Number
    3004209178-2011-02426
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION USING THE PATIENT PROGRAMMER. A POWER-ON-RESET (POR) CONDITION WAS NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# V164538| ACCESSORY: MODEL 37752, LOT# NKA116856N| EXTENSION: MODEL, 37082, LOT# NKB015344N| LEAD: MODEL 3778, LOT# V277486006| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# V164538| IMPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE116859N