BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3904262 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-08765
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    November 8, 2011
    Report Date
    May 11, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PHYSICIAN WILL CONTINUE MONITORING. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED. THE IMPLANTABLE DEFIBRILLATION LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384105 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R 0184| N118| 1280| 4473| 4472| 4518