BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 1926481 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14348
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 11, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS DISTORTED, AND WAS FRACTURED DUE TO OVERSTRESS, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THE LEAD APPEARED DAMAGED AT IMPLANT. (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR FRACTURED. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS FRACTURED AND CUT, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE OUTER INSULATION WAS KINKED/BUCKLED, HAD A COSMETIC CUT, AND A COSMETIC DEPRESSION, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION, AND IT WAS BREACHED AND HAD A DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THE LEAD WAS STRETCHED. (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE OUTER INSULATION WAS BREACHED AND HAD A DEPRESSION. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE PROXIMAL CONDUCTOR MELTED, THE OUTER INSULATION WAS PULLED APART DUE TO OVERSTRESS, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THE LEAD WAS STRETCHED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE LEADS IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A FRACTURE ON THE RIGHT VENTRICULAR (RV) LEAD. THE PHYSICIAN ATTEMPTED TO REPLACE THE PACE/SENSE PORTION WITH A PREVIOUSLY CAPPED RV PACE/SENSE LEAD, BUT WHEN CONNECTED THERE WAS CROSSTALK, OVERSENSING, AND NOISE ON BOTH THE ATRIAL AND RV EGMS VIA THE DEVICE. UPON REMOVAL OF ALL THREE LEADS, INSULATION BREAKS WERE NOTED ON THE ATRIAL AND PREVIOUSLY CAPPED RV LEAD, AND THE IMPLANTER STATED THE INSULATION WAS WORN OFF. A NEW PACE/SENSE LEAD WAS ATTEMPTED, BUT THE PHYSICIAN STATED THE LEAD WAS BAD DUE TO "LUMEN SQUEEZED." THE LEAD WAS NOT USED, AND ALL LEADS WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE Z NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5054 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| O| R 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4194 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB