BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK DSP

    MDR report key: 3050033 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03614
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 11, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PORTION OF THIS LEAD HAS BEEN RETURNED. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE RETURNED PORTION OF THE LEAD WAS PERFORMED. VISUAL OBSERVATION REVEALED THAT THE RETURNED SEGMENT (DISTAL SHOCKING COIL) THAT WOULD BE LOCATED IN CLOSE PROXIMITY TO THE DISTAL TIP SECTION WAS EXTREMELY STRETCHED, SEVERED AND A SUTURE TIED-DOWN. ANALYSIS CONCLUDED THAT THE DAMAGES TO THE LEAD WERE LIKELY A RESULT OF THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE EXPLANT OF ANOTHER MANUFACTURER'S RIGHT ATRIAL (RA) LEAD, THE PHYSICIAN ELECTED TO ATTEMPT TO EXPLANT THIS CHRONIC IMPLANTABLE DEFIBRILLATION LEAD DUE TO THE AGE OF THE LEAD. THE LEAD BROKE DURING THE EXPLANT ATTEMPT AND APPROXIMATELY ONE THIRD OF THE DISTAL PORTION OF THE LEAD REMAINS IN THE HEART. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ANOTHER MANUFACTURER'S IMPLANTABLE DEFIBRILLATION LEAD WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151981 ENDOTAK DSP IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening 4087| MISMATCH| 4269| S606| 1388T| 1851| 1810| 0125| E142| T167| 4088