BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2200633 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11033
    Event Type
    Injury
    Date Received
    August 11, 2011
    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
    CO, 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 PARTIAL LEAD WAS RETURNED IN SEGMENTS. NO ANOMALIES WERE FOUND. HOWEVER, THERE WAS APPARENT EXPLANT DAMAGE. THE DEFIBRILLATOR CONDUCTOR WAS DISTORTED AND HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE EXPOSED DEFIBRILLATOR COIL HAD A WHITE SUBSTANCE. THE INNER TUBING WAS KINKED/BUCKLED. THE OUTER INSULATION HAD COSMETIC DEPRESSION. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE HELIX/LOBE MECHANISM (SLEEVE HEAD). (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND; HOWEVER, VISUAL ANALYSIS REVEALED APPARENT EXPLANT DAMAGE. THE PROXIMAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED),. THE OUTER INSULATION HAD A BREACHED CUT AND A COSMETIC DEPRESSION. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND A DECREASE IN IMPEDANCE. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE PATIENT HAD RECEIVED A SHOCK, THAT THEIR LEADS WERE TANGLED, AND THAT THE DEVICE HAD BEEN FLIPPING OVER IN THEIR CHEST. THE PATIENT DEVELOPED A BLOOD CLOT IN THEIR LEFT ARM AND HAD PAIN AND SEVERE SWELLING. THE PATIENT WAS PUT ON BLOOD THINNERS AND REQUIRED REHABILITATION. THE DEVICE IS STILL IN USE. IT WAS FURTHER REPORTED THAT ONE OF THE PATIENTS LEADS HAD MOVED WITHIN TWO MONTHS OF IMPLANT AND CAUSED HICCUPS. THE LEAD WAS REPOSITIONED AND THE PATIENT DEVELOPED AN INFECTION WHICH EVENTUALLY RESOLVED. NO FURTHER 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 57 YR Hospitalization| R