BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3790557 · Received May 5, 2014

    Report

    Report Number
    2124215-2014-05592
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    January 16, 2014
    Report Date
    April 9, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH ANALYSIS WAS PERFORMED. THE PRODUCT ANALYSIS DID NOT CONFIRM THAT THE LEAD PERFORATED AS THE LEAD TIP AND HELIX HAVE NO VISIBLE SIGNS OF DAMAGE OR DEFECT WHICH WOULD LEAD TO PERFORATION.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD PERFORATED. ON FLUOROSCOPY, IT DID NOT APPEAR TO HAVE PERFORATED, HOWEVER, THERE WAS PERFUSION AND 500 CUBIC CENTIMETERS (CC) OF FLUID HAD TO BE EVACUATED. THE PHYSICIAN THOUGHT THAT A MICROPERFORATION. THE LEAD WAS REPOSITIONED TWICE BUT THE PHYSICIAN STOPPED AFTER THE PERFUSION. THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269270 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R