BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK C

    MDR report key: 3213059 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10162
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    September 28, 2011
    Report Date
    June 24, 2013
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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 THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD UNDERWENT A POCKET REVISION PROCEDURE DUE TO DEVICE MIGRATION AND SOME EROSION AT THE IMPLANT SITE. THERE WAS FLUID AND PUSS NOTED IN THE POCKET. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, THE DEVICE ERODED AGAIN AND THE LEAD WAS SURGICALLY ABANDONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314196 ENDOTAK C IMPLANTABLE LEAD NVY HISTORICAL CPI ST. PAUL 0074

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R (B)(4)| H125| 4525| 0063| 6836| 1283| 0940| 0074| 0040| 4269| (B)(4)| 1746| 1705| 1857| (B)(4)