BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1852200 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-16152
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    June 11, 2010
    Report Date
    July 12, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATIONS INDICATED ONLY THE PROXIMAL SEGMENT OF THE RV LEAD WAS RETURNED. THERE WERE SET SCREW MARKS NOTED ON ALL TERMINALS, THERE WERE DEFORMED CONDUCTOR COILS, AND PUNCTURE HOLES IN THE INSULATION FROM SOME TYPE OF GRABBING TOOL. THE LEAD SEGMENT WAS CURLED ALONG THE WHOLE LENGTH, AND THERE WAS BLOOD/BODY FLUID NOTED IN THE LUMENS. THIS SEGMENT OF THE RV LEAD PASSED THE CONTINUITY TEST WITH MANIPULATION. INITIAL ALLEGATIONS OF NOISE AND DISLODGEMENT COULD NOT BE CONFIRMED BY ANALYSIS OF THE LEAD SEGMENT RETURNED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISY SIGNALS IN THE RV CHANNEL. IT WAS NOTED THIS PATIENT DID NOT EXPERIENCE ANY INAPPROPRIATE THERAPY. ANOTHER FOLLOW-UP WAS PERFORMED, AND NOISE WAS NOT REPRODUCIBLE THROUGH POCKET MANIPULATION. THERE WAS ONLY THE ONE EPISODE OF NOISE RECORDED. IT WAS NOTED THIS PATIENT HAD A NEW ANTI-THEFT SYSTEM PUT IN AT WORK, BUT BSC TS DOES NOT BELIEVE THE NOISE LOOKED LIKE ELECTROMAGNETIC INTERFERENCE (EMI). BSC TS DISCUSSED THAT A REVISION PROCEDURE IS NOT NECESSARY IF ALL OTHER MEASUREMENTS ARE WITHIN NORMAL RANGE, BUT THAT IT IS THE PHYSICIAN'S DECISION ON WHAT SHE/HE WOULD LIKE TO DO. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT ALL MEASUREMENTS WERE OUT OF RANGE. WHEN THE POCKET WAS MANIPULATED NOISE WAS OBSERVED, AND THE PHYSICIAN BELIEVED AFTER REVIEWING AN X-RAY THAT THE RV LEAD HAD DISLODGED. THE PHYSICIAN ELECTED TO CAP AND ABANDON THIS LEAD DUE TO DIFFICULTIES WITH EXPLANTING IT. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1