BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1994353 · Received January 14, 2011

    Report

    Report Number
    3004209178-2011-00373
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 4, 2011
    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
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED STIMULATION IN THE WRONG LOCATION. IF HE INCREASED THE STIMULATION ABOVE 3.0 HE FELT PAINFUL STIMULATION IN HIS CHEST. HE HAS HAD THIS PROBLEM FOR A WHILE BUT THE CONFIRMED LEAD BREAK WAS NOT FOUND UNTIL (B)(6). ADDITIONAL INFO HAS BEEN REQUESTED.

    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 63 YR LEAD: MODEL 3778, LOT# V192803039| IMPLANTED:| LEAD: MODEL 3778, LOT# V065566025| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE124320N| ACCESSORY: MODEL 37752, LOT# NKA123681N| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB050883V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB049558V| IMPLANTED: