BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210354 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08182
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 14, 2013
    Report Date
    July 17, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE LEAD HAS NOT YET BEEN RECEIVED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE LEAD WAS THOROUGHLY INSPECTED AND ANALYZED. THE LEAD WAS RETURNED SEVERED 133 MILLIMETERS (MM) FROM THE TERMINAL PIN, IN TWO SEGMENTS, TOTALING A LENGTH OF 600MM. THE RS- CONDUCTOR COIL EXTENDED BEYOND THE SEVERED END OF THE TIP INSULATION BY 128MM. THE EXTRACTING STYLET WAS RETURNED STUCK IN THE TIP SEGMENT OF THE LEAD. THE RS- CONDUCTOR COIL WAS EXTREMELY STRETCHED IN THE TIP SEGMENT. THERE WERE CUTS NOTED IN THE INSULATION AND LASER EXTRACTION DAMAGE WAS NOTED ON THE TRILUMEN INSULATION. THE DISTAL END OF THE PROXIMAL SPRING ELECTRODE WAS SEPARATED FROM THE LEAD BODY INSULATION AND THE PROXIMAL END OF THE DISTAL SPRING ELECTRODE WAS SEPARATED FROM THE LEAD BODY INSULATION. TISSUE WAS ALSO NOTED AROUND THE DISTAL END OF THE DISTAL SPRING ELECTRODE. THE DISTAL COIL WAS DEFORMED AT THE DISTAL END. BLOOD/BODY FLUID WAS NOTED IN THE HELIX HOUSING. THE HELIX WAS EXTENDED AND WAS NOTED TO BE ENTWINED IN THE HELIX. DETAILED ANALYSIS FOUND AN INSULATION ABRASION THROUGH TO THE RS- LUMEN 140-153MM FROM THE TIP. THE ABRASION WAS A LONG, SMOOTH ABRASION INDICATIVE OF LEAD-ON-LEAD CONTACT. THE ABRASION WAS LOCATED BETWEEN THE DISTAL AND PROXIMAL SPRING ELECTRODES WHICH WOULD HAVE BEEN LOCATED WITHIN THE HEART REGION. THE LEAD¿S RS- CONDUCTOR COIL WAS FRACTURED APPROXIMATELY 520MM FROM THE TIP. THE LOCATION AND TYPE OF FRACTURE ON THIS LEAD WAS CONSISTENT WITH A FATIGUE FRACTURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED NOISE THAT WAS OVERSENSED AND LED TO INAPPROPRIATE THERAPIES AND PACING INHIBITION OF UNKNOWN DURATION. THE PATIENT HAD REPORTED FEELING LIGHT HEADED. THE PATIENT WAS SEEN FOR A LEAD REVISION PROCEDURE WHERE THE LEAD WAS EXPLANTED AND REPLACED. THE LEAD IS TO BE RETURNED FOR ANALYSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    THIS LEAD HAS BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310781 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R VEDR01| 0184| E110| 4524| 4024