BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE

    MDR report key: 3213168 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09895
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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 IMPLANTED WITH THIS RIGHT VENTRICULAR (RV) LEAD PRESENTED TO THE HOSPITAL FOLLOWING A SYNCOPAL EPISODE. THE PATIENT IS PACEMAKER DEPENDENT AND THE LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE (LOC) RESULTING IN ASYSTOLE FOR GREATER THAN TWO SECONDS. AN INVASIVE PROCEDURE WAS PERFORMED. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312547 SELUTE IMPLANTABLE LEAD NVN HISTORICAL PUERTO RICO 4185

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| L| R 0937| 4185| 0505| K064| MISMATCH| 4136| (B)(4)