BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK DSP

    MDR report key: 2050299 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03205
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    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 A ROUTINE SYSTEM FOLLOW-UP, HIGH OUT OF RANGE SHOCKING IMPEDANCES WERE EXHIBITED WITH THIS RIGHT VENTRICULAR LEAD; LEAD FRACTURE CONFIRMED VIA X-RAY IMAGING. THE PHYSICIAN COMMENTED THAT THE LEAD FRACTURE WAS OBSERVED AROUND THE INSERTION SITE OF THE SUBCLAVIAN VEIN, THUS LEAD DAMAGE LIKELY CAUSED BY BENDING AROUND THE SITE. DURING THE REVISION PROCEDURE, THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED WITH ANOTHER BOSTON SCIENTIFIC LEAD. NO SPECIFIC ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK DSP IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention 1790| 0125