BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE PICOTIP

    MDR report key: 3213140 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10111
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    October 5, 2010
    Report Date
    June 5, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P950001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    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 DISPLAYED INCREASING RV THRESHOLD MEASUREMENTS TO 2.2V @ 1MS IN BIPOLAR AND 2.3V @ 1.0MS IN UNIPOLAR. THE PHYSICIAN HAD ELECTED TO MONITOR. ADDITIONALLY, UPON REVIEW OF THE ARRHYTHMIA LOGBOOK, TWO EPISODES OF LOSS OF CAPTURE (LOC) WAS OBSERVED DURING A VENTRICULAR TACHYCARDIA (VT). IT WAS UNKNOWN IF THE PATIENT EXPERIENCED ADVERSE EFFECTS AS A RESULT. THE PHYSICIAN CONTINUES TO MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313216 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4034

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR 1286| 4034| 4036| 1290