BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3921820 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-12500
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    March 15, 2014
    Report Date
    May 12, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW, OUT OF RANGE PACING LEAD IMPEDANCE MEASUREMENT LESS THAN 200 OHMS DETECTED VIA THE PATIENT REMOTE MONITORING SYSTEM. SUBSEQUENT INFORMATION WAS RECEIVED INDICATING THAT A SURGICAL REVISION WAS DONE WHEREIN THE RV LEAD WAS REPLACED DUE TO NOISE OBSERVED DURING POCKET MANIPULATION WHICH WAS BELIEVED TO BE DUE TO MEDIAL IMPLANT LOCATION AND SUBCLAVIAN CRUSH; NO REPORT OF OVERSENSING. THE LEAD WAS TESTED PRIOR TO THE CASE AND NORMAL MEASUREMENTS WERE OBSERVED. THE RV LEAD WAS SURGICALLY ABANDONED WHILE THE DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400147 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R 4469| 0184| T167