BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE

    MDR report key: 2052605 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03489
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION REGARDING THIS CASE IS EXPECTED, WE CONSIDER THIS EVENT CLOSED. IF NEW DETAILS ARE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP, ABNORMAL PACING IMPEDANCES, LOSS OF CAPTURE AND MUSCLE STIMULATION WERE OBSERVED WITH THIS RIGHT VENTRICULAR LEAD. ADDITIONALLY, IT WAS NOTED THAT PACING INHIBITION OF GREATER THAN 2 SECONDS HAD BEEN OBSERVED. DURING INTERVENTION, THE LEAD WAS SURGICALLY ABANDONED AND ANOTHER LEAD SUCCESSFULLY IMPLANTED IN THE ABSENCE OF SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4285

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention 4285| 4244| 1276