BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 3232007 · Received July 17, 2013

    Report

    Report Number
    2124215-2013-11321
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    April 30, 2013
    Report Date
    June 13, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THAT A LEAD REVISION WAS LATER PERFORMED. A FRACTURE WAS SUSPECTED ON THE LEAD, AND THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE LEAD IS NOT ABLE TO BE RETURNED, SO CLINICAL OBSERVATIONS CANNOT BE CONFIRMED. 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 THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE THAT WAS NON-PHYSIOLOGIC IN APPEARANCE. LEAD MEASUREMENTS WERE NOTED TO BE WITHIN NORMAL RANGE. THERE WERE NO PAUSES IN PACING OF GREATER THAN TWO SECONDS DUE TO THE OVERSENSING OF THE NOISE. THE DEVICE WAS REPROGRAMMED AND THE LEAD REMAINED IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332591 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4341

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R MISMATCH| 4341| 1280