BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3912612 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-12881
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 HAD PERFORATED. ADDITIONAL INFORMATION RECEIVED INDICATES THE PERFORATION WAS CONFIRMED THROUGH FLUOROSCOPY AND NO INTERVENTION WAS DONE. THE RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390577 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R E143| 5076| 0180