BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2200586 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-03588
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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): CALCULATIONS BASED ON IMPLANT PARAMETERS INDICATE THAT THE DEVICE HAD MET ITS 99.9% EXPECTED LONGEVITY. ANALYSIS OF THE DEVICE MEMORY FOUND THE ERI (ELECTIVE REPLACEMENT INDICATOR) IS THE RESULT OF HIGH INTERNAL BATTERY RESISTANCE. THIS DEVICE IS PART OF THE FIELD ACTION AND HAS TESTED CONSISTENT WITH THE FIELD ACTION. (B)(4): THE PARTIAL LEAD IN SEGMENTS WAS RETURNED, ANALYZED, AND THE INNER INSULATION HAD BREACHED METAL INDUCED OXIDATION. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), ALL INSULATORS WERE MELTED, THE INNER INSULATION HAD COSMETIC METAL INDUCED OXIDATION, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND SLEEVEHEAD, AND THE LEAD WAS STRETCHED. IT WAS ALSO NOTED THAT THE OUTER INSULATION WAS MELTED, WAS KINKED/BUCKLED, HAD ENVIRONMENTAL STRESS CRACKING, HAD A COSMETIC CUT, HAD A WHITE SUBSTANCE, AND HAD A COSMETIC DEPRESSION. (B)(4): THE PARTIAL LEAD IN SEGMENTS WAS RETURNED, ANALYZED, AND THE INNER INSULATION HAD BREACHED METAL INDUCED OXIDATION. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE PROXIMAL CONDUCTOR WAS MELTED, THE INNER INSULATION HAD COSMETIC METAL INDUCED OXIDATION, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND SLEEVEHEAD, AND THE LEAD WAS STRETCHED. IT WAS ALSO NOTED THAT THE OUTER INSULATION WAS MELTED, HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, HAD A BREACHED CUT, HAD A WHITE SUBSTANCE, AND HAD A COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ATRIAL LEAD IMPEDANCE WAS MEASURING LOWER. IT HAD BEEN NORMAL BUT HAD CHANGED SUDDENLY (B)(6) AGO. THE THRESHOLD HAS ALSO INCREASED. SUSPECT LEAD INSULATION FAILURE. THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS ALSO HAD APPARENT LEAD FRACTURES. BOTH LEADS WERE EXPLANTED AND REPLACED. THE DEVICE WAS REPLACED DUE TO ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R