BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 3211052 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08795
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IMPLANTED WITH PROGRAMMED OUTPUTS CHANGED FOR OPTIMIZATION. 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 A LOSS OF CAPTURE (LOC) THAT RESULTED IN A PAUSE FOR GREATER THAN TWO SECONDS. PACING SPIKES WERE ON TELEMETRY WERE OBSERVED DURING THE PAUSES. IMPEDANCE MEASUREMENTS WERE STABLE. INCREASE IN PACING THRESHOLDS WERE NOTED. THE PATIENT WAS BEING MOVED OVER TO A BED DURING A HOSPITAL STAY FOR A NON-DEVICE RELATED PROCEDURE WHEN THE LOC WAS OBSERVED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310724 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4034

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Life Threatening| R 1296| 5554| 1274| 4034