BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2220226 · Received August 16, 2011

    Report

    Report Number
    3004209178-2011-06424
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL OF EXTENSION (B)(4) DISCOVERED THAT ALL CONDUCTOR WIRES WERE BROKEN 27.5 CM FROM THE PROXIMAL END AND ALL CIRCUITS WERE OPEN. ANALYSIS OF EXTENSION (B)(4) DISCOVERED THAT ALL CONDUCTOR WIRES WERE BROKEN 19.8 CM FROM THE PROXIMAL END AND ALL CIRCUITS WERE OPEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A SUDDEN LOSS OF STIMULATION AFTER LIFTING A TIRE. IMPEDANCES ON ALL ELECTRODES WERE MEASURED AT OVER 40,000 OHMS. THE EXTENSIONS WERE REPLACED ON (B)(6) 2011 AND RETURNED TO MFR FOR ANALYSIS.

    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 23 YR Required Intervention EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA147852N| IMPLANTED:| LEAD: MODEL 3778, LOT# V498803030| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V498803032| EXTENSION: MODEL 37081, LOT# NJB087568V| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE160587N| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB082949V