BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2812224 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16169
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 DEVICE MET 80% OF EXPECTED LONGEVITY. 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. (B)(4) - THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) - THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE PROXIMAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THE DEFIBRILLATION CONDUCTOR WAS DISTORTED, SEVERAL CONDUCTORS WERE DISTORTED, THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING WAS KINKED/BUCKLED, THE OUTER INSULATION WAS MELTED, THE OUTER TUBING OVERLAY WAS MELTED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND HAD SHORT LONGEVITY. IT WAS ALSO REPORTED THAT THERE WAS A LEAD INTEGRITY ALERT ON THE RIGHT VENTRICULAR LEAD FOR A RISE IN IMPEDANCE. FRACTURE WAS SUSPECTED. LOW R WAVES WERE ALSO NOTED ON THE RIGHT VENTRICULAR LEAD. IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD HAD LONG TERM FAR FIELD OVERSENSING. THE DEVICE AND BOTH LEADS WERE EXPLANTED AND 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 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R 4194 IMPLANTABLE PACING LEAD