BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2201339 · Received August 3, 2011

    Report

    Report Number
    3004209178-2011-06022
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 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 THAT, AT FINAL IMPLANTATION OF THE PT'S IMPLANTABLE NEUROSTIMULATOR, ALL OF THE IMPEDANCE READINGS WERE NORMAL EXCEPT FOR ELECTRODE 15, ON ONE OF THE LEADS, WHICH SHOWED HIGH IMPEDANCES. NO PT SYMPTOMS OR INJURY WERE REPORTED. THE PT REC'D GOOD STIMULATION. SEE ALSO MFR REPORT # 3007566237201106023 FOR INFO RELATED TO THE NEUROSTIMULATOR INITIALLY IMPLANTED DURING THE SAME PROCEDURE.

    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 68 YR IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA154283N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V551589010| LEAD: MODEL 3778, LOT# V445509030| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE166671N