BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1924107 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13399
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    September 2, 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
    MD, 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) NO ANOMALIES WERE FOUND; FULL LEAD WAS RETURNED FOR ANALYSIS. FURTHER TESTING REVEALED PROXIMAL CONDUCTOR WAS DISTORTED, DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) NO ANOMALIES WERE FOUND; FULL LEAD WAS RETURNED FOR ANALYSIS. FURTHER TESTING REVEALED BLOOD IN/ON HELIX MECHANISM SLEEVE HEAD, AND BLOOD IN/ON HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL AND LEFT VENTRICULAR LEADS WERE DISLODGED AND THRESHOLDS WERE HIGH/UNSTABLE/UNMEASURABLE. THE LEFT VENTRICULAR LEAD ALSO HAD MUSCLE/NERVE STIMULATION. BOTH LEADS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 58 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB