BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 2203319 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11859
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 10, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 THE DISTAL CONDUCTOR WAS DISTORTED. IT WAS NOTED THAT ALL CONDUCTORS WERE DISTORTED, THE DEFIBRILLATION COIL WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE INNER TUBING WAS KINKED/BUCKLED, ALL INSULATORS HAS COSMETIC ENVIRONMENTAL STRESS CRACKING BREACH, THERE WAS BLOOD IN/ON THE HELIX MECHANISM (SLEEVE HEAD), THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE. THE ANALYST COMMENTED THAT THE HELIX CAN NOT EXTEND AND RETRACT DUE TO DISTAL CONDUCTOR DISTORTION WITHIN THE CONNECTOR. (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. ANALYST COMMENTED THAT THE ORIGINAL STYLET WAS USED TO PERFORM THE TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS GOING IN TO HAVE HIS LEADS TUNNELED FROM THE RIGHT SIDE TO THE LEFT SIDE. DURING THIS PROCESS THE LEADS BECAME DISLODGED. THE PHYSICIAN TRIED SEVERAL ATTEMPTS TO REPOSITION THE LEADS AND EVENTUALLY BEGAN HAVING DIFFICULTIES INSERTING STYLETS IN THE LEADS. 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 CAPSURE SENSE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4574 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB