BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2211097 · Received August 8, 2011

    Report

    Report Number
    3004209178-2011-06121
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Report Date
    July 12, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011, IMPEDANCES >10,000 OHMS WERE MEASURED ON ALL ELECTRODE PAIRS. AT A PREVIOUS VISIT, THERAPY IMPEDANCE WAS >4,000 FOR ONE OF THE PROGRAMS, BUT OVERALL STIMULATION WAS OKAY THROUGHOUT THE OTHER PROGRAM. THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION, AND FELT UNEXPECTED STIMULATION WHEN THE NEUROSTIMULATOR WAS OFF. IT WAS UNCLEAR WHETHER THE DEVICE WAS TRULY OFF DURING THE SYMPTOMS, WHICH BEGAN OCCURRING FOLLOWING A FALL. IT WAS UNKNOWN IF MOVEMENT CAUSED CHANGES IN STIMULATION. IT WAS NOTED THAT THERE MAY BE SOMETHING AT THE ANCHORING SITE THAT LOOKED "OFF." 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 ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESSORY: MODEL 37752, LOT# NKA122916N| LEAD: MODEL 3778, LOT# V255902017| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE133592N| IMPLANTED:| LEAD: MODEL 3778, LOT# V255902018| IMPLANTED: