BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3910532 · Received July 2, 2014

    Report

    Report Number
    2124215-2014-09667
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    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 THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. IN ADDITION, THIS LEAD WAS LASER EXTRACTED AND THE 14 FRENCH EXTRACTION SHEATH BECAME STUCK ON THE DISTAL COIL. DURING LEAD INSPECTION IT WAS FOUND THAT THE GORE COVERING ON THE DISTAL COIL WAS BUNCHED UP AND WAS THOUGHT TO BE THE REASON WHY THE SHEATH WAS STUCK. THIS RV LEAD WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388055 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R T175| E141| 0185