BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM III VR

    MDR report key: 1981061 · Received February 8, 2011

    Report

    Report Number
    6000094-2011-00020
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    September 1, 2009
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S15
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. HIGH RESISTANCE/IMPEDANCE. PATIENT ALERT FOR RV. PACE LEAD Z >2000 OHMS ON (B)(6)-2010 03:00:06. RESISTANCE/IMPEDANCE INCREASE. WEEKLY PACING LOG DATA SHOWS MIN V.PACE AND MAX V.PACE GRADUALLY INCREASES FROM MAX V.PACE=840 TO 2187 OHMS PEAK BETWEEN (B)(6)-2009 AND (B)(6)-2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD PACE/SENSE IMPEDANCE HAS BEEN SLOWLY RISING OVER THE PAST YEAR, REACHING ELEVATED VALUES. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD DIED APPROXIMATELY THREE WEEKS AFTER THIS REPORT. THE CAUSE OF DEATH IS BEING REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM III VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7231CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB