BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 2781730 · Received October 11, 2012

    Report

    Report Number
    6000094-2012-01913
    Event Type
    Injury
    Date Received
    October 11, 2012
    Manufacturer
    MEDTRONIC S.A.
    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) THE PARTIAL LEAD IN SEGMENTS WAS RETURNED, ANALYZED, AND THE OUTER INSULATION HAD A BREACHED DEPRESSION. IT WAS ALSO NOTED THAT ALL CONDUCTORS WERE STRETCHED, ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE INNER INSULATION WAS KINKED/BUCKLED, THE OUTER INSULATION WAS KINKED/BUCKLED, ALL THE INSULATION WAS TORN, THE OUTER INSULATION HAD A WHITE SUBSTANCE, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, AND THE LEAD WAS STRETCHED. THE ANALYST ALSO NOTED THAT THERE WAS SEVERE EXPLANT DAMAGE. (B)(4) THE FULL LEAD IN SEGMENTS WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT ALL CONDUCTORS WERE STRETCHED, ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER INSULATION WAS KINKED/BUCKLED, THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A WHITE SUBSTANCE, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, THERE WAS TISSUE ON THE HELIX, THE LEAD WAS STRETCHED, AND THERE WAS APPARENT EXPLANT DAMAGE. THE ANALYST NOTED THAT THERE WAS SEVERE EXPLANT DAMAGE. (B)(4) THE DEVICE DID NOT MEET EXPECTED LONGEVITY. ANALYSIS OF THE DEVICE AND INTERNAL COMPONENTS WERE AS EXPECTED FOR A PACEMAKER AT ERI (ELECTIVE REPLACEMENT INDICATOR). WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD AN ACUTE INCREASE IN THE PACING THRESHOLD. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD WAS REMOVED DUE TO POTENTIAL DAMAGE DURING THE RIGHT VENTRICULAR LEAD EXTRACTION. BOTH LEADS WERE REMOVED AND REPLACED. THE DEVICE WAS REPLACED DUE TO APPROACHING 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 S.A. P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R