BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 3210889 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08830
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) IMPEDANCES OF GREATER THAN 2000 OHMS AS WELL AS HIGH THRESHOLDS. AS A RESULT THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. THE PATIENT RECEIVED AN ENTIRELY NEW SYSTEM ON THE OPPOSITE SIDE, SO THE ATRIAL LEAD AND THE DEVICE WERE ALSO REMOVED FROM SERVICE. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310135 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4034

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| L| R K173| 4135| 1290| 4053| 4136| 4034