BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211619 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-10229
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANTATION OF THIS RIGHT VENTRICULAR (RV) LEAD, THE LEAD HAD TO BE REPOSITIONED SEVERAL TIMES AS THE VALUES WERE NOT ACCEPTABLE TO THE PHYSICIAN. IT WAS THEN NOTED THAT THE PATIENT HAD EXPERIENCED A PERFORATION. PERICARDIOCENTESIS WAS PERFORMED AS A RESULT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312031 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0275

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R N140| 4542| 0275| 4135