BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4140495 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17467
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 11, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE DEVICE, RIGHT VENTRICULAR (RV) AND NON-BSC SUBCUTANEOUS LEAD DISPLAYED A SHOCK IMPEDANCE MEASUREMENT GREATER THAN 200 OHMS. TECHNICAL SERVICES WAS CONSULTED AND DISCUSSED TROUBLESHOOTING. A REVISION PROCEDURE WAS PERFORMED AND THE NON-BSC SUBCUTANEOUS LEAD WAS DETERMINED TO BE THE CAUSE OF THE OUT OF RANGE MEASUREMENT AND WAS EXPLANTED. THE DEVICE AND BSC RV LEAD REMAIN IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618234 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| R H227| 0185| 4542| 4592| 4555| 6996SQ| N161| 4135