BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2100333 · Received May 13, 2011

    Report

    Report Number
    3007566237-2011-03513
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 26, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    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 HIGH IMPEDANCES WERE SEEN (>2000 OHMS) ON SOME OF THE PATIENT'S LEAD ELECTRODE UNIPOLAR PAIRS. THE PATIENT WAS PROGRAMMED WITH CASE TO ELECTRODE #3 WHICH SHOWED NORMAL IMPEDANCES. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC NEUROMODULATION 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| LEAD: MODEL LEADMVD, LOT# UNKNOWN| EXPLANTED: