BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM III VR

    MDR report key: 2203473 · Received August 11, 2011

    Report

    Report Number
    6000094-2011-01588
    Event Type
    Injury
    Date Received
    August 11, 2011
    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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS NOT ANALYZED AS IT MET EXPECTED LONGEVITY. (B)(4): DEFIB CONDUCTOR FRACTURED, THE DISTAL CONDUCTOR WAS DISTORTED, SEVERAL CONDUCTORS WERE DISTORTED, THE DEFIBRILLATION CONDUCTOR FRACTURED DUE TO OVERSTRESS, THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE INNER INSULATION WAS KINKED/BUCKLED, THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY WAS MELTED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION WAS BREACHED AND HAD ENVIRONMENTAL STRESS CRACKING (NON-ELECTRICAL), THE OUTER TUBING WAS TORN, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM; FULL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4): DEFIB CONDUCTOR FRACTURED, THE DISTAL CONDUCTOR WAS DISTORTED, SEVERAL CONDUCTORS WERE DISTORTED, THE DEFIBRILLATION CONDUCTOR FRACTURED DUE TO OVERSTRESS, THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE INNER INSULATION WAS KINKED/BUCKLED, THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY WAS MELTED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION WAS BREACHED AND HAD ENVIRONMENTAL STRESS CRACKING (NON-ELECTRICAL), THE OUTER TUBING WAS TORN, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM; FULL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD AND DEVICE HAD T-WAVE OVERSENSING AND HIGH IMPEDANCE. THE LEAD AND DEVICE WERE REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    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 Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD