BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2050343 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-05005
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME NO ADDITIONAL INFORMATION HAS BEEN COMMUNICATED. IF NEW DETAILS ARE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A RECENT CLINICAL FOLLOW-UP, HIGH OUT OF RANGE SHOCKING IMPEDANCES WERE EXHIBITED WITH THIS RIGHT VENTRICULAR LEAD WITH INAPPROPRIATE SHOCKING REPORTED. THE PHYSICIAN SUSPECTED A CONDUCTOR FRACTURE OR INSULATION ISSUES AS A CONTRIBUTING FACTOR. SUBSEQUENTLY DURING LEAD EXPLANT, IT WAS CONFIRMED THE LEAD WAS FRACTURED AND 'BROKE' DURING EXTRACTION. ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE REMAINING LEAD SEGMENT. ADDITIONALLY, IT WAS REPORTED THAT ANOTHER CHRONIC LEAD (4244/(B)(4)) HAD BEEN FRACTURED BY THE PHYSICIAN DURING THE EXTRACTION ATTEMPTS. WHILE NO ADVERSE PATIENT EFFECTS WERE REPORTED, ALL LEADS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention 1861| T165| 0185| 4244| 0145| E110