BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2190985 · Received July 19, 2011

    Report

    Report Number
    3004209178-2011-05586
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 24, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS COUPLING AND/OR COMMUNICATION ISSUES FOLLOWING A FALL FROM (B)(6). THE PT HAD NOT CHARGED THE DEVICE IN OVER (B)(6) AND HAD NOT USED THE STIMULATION SINCE THE FALL. AN OVER-DISCHARGE WAS SUSPECTED. THE PT HAD AN APPOINTMENT ON (B)(6) 2011 AND STILL HAD CONCERNS ABOUT THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP 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 56 YR EXPLANTED:| ACCESSORY: MODEL 37651, LOT# NKA126153N| LEAD: MODEL 3777, LOT# V158546016| IMPLANTED:| LEAD: MODEL 3777, LOT# V158546015| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE123399N