BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1921119 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12372
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    August 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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) ANALYSIS CONFIRMED A DEPLETED BATTERY DUE TO HIGH CURRENT IN THE HYBRID. THE HIGH CURRENT DRAIN WAS CAUSED BY AN ANOMALY ON THE REGULATED VOLTAGE. THE HIGH CURRENT DRAIN WAS NOT SUCCESSFULLY ISOLATED AND THEREFORE THE CAUSE FOR THE ANOMALY WAS NOT DETERMINED. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND THE LEAD WAS STRETCHED. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS DISTORTED, THE PROXIMAL CONDUCTOR WAS CUT, ALL CONDUCTORS WERE STRETCHED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE PROXIMAL CONDUCTOR WAS MELTED, THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER INSULATION WAS KINKED/BUCKLED, THE INNER INSULATION WAS TORN, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THE HELIX/LOBE WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE.

    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 DEVICES IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED RECOMMENDED REPLACEMENT TIME (RRT) SOONER THAN EXPECTED BY THE CLINICIANS. DURING DEVICE CHANGE OUT, THE SUPERIOR VENA CAVA (SVC) AND RIGHT VENTRICLE (RV) DEFIBRILLATION COIL IMPEDANCES WERE HIGH AND VARYING. THE CALLER WANTED TO KNOW HOW THEY COULD TELL WHERE THE LEAD WAS FRACTURED. THE RV LEAD WAS REMOVED AND REPLACED. DURING EXTRACTION OF RV LEAD, THE RIGHT ATRIAL (RA) LEAD WAS DAMAGED AND WAS REPLACED. THE DEVICE WAS REMOVED 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD