BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040846 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00952
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 5, 2013
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE INITIAL NEEDLE STICK TO OBTAIN ACCESS TO THE SUBCLAVIAN VEIN TO IMPLANT THIS RIGHT VENTRICULAR LEAD, THE PATIENT SUSTAINED A PNEUMOTHORAX DUE TO A SUSPECTED PERFORATION OF THE LUNG. THERE WERE NO ADDITIONAL SYMPTOMS AND THE PHYSICIAN CONTINUED THE IMPLANT SUCCESSFULLY AND UN- EVENTFULLY. ALL LEADS PARAMETERS WERE NORMAL AND DFT WAS PERFORMED SUCCESSFULLY. THE LEAD REMAINS IMPLANTED AND IN SERVICE AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142686 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L