BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE PICOTIP

    MDR report key: 4132233 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14929
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    January 1, 2013
    Report Date
    July 23, 2014
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION WAS PROVIDED FROM THE FIELD REGARDING THIS EVENT. 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 A PATIENT EXPERIENCED BRADYCARDIA DUE TO PACING INHIBITION INVOLVING THEIR PACEMAKER AND RIGHT ATRIAL (RA) LEAD. IT IS UNKNOWN IF THIS PATIENT EXPERIENCED ASYSTOLE OF GREATER THAN TWO SECONDS. THRESHOLDS WERE ALSO NOTED TO HAVE INCREASED. THE OUTPUT WAS ADJUSTED AND THE INHIBITION STOPPED. THIS ALL OCCURRED ONE DAY POST ABLATION SURGERY. THE PATIENT WILL CONTINUE TO BE MONITORED AND THE RA AND PACEMAKER CONTINUE TO REMAIN IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613122 SELUTE PICOTIP IMPLANTABLE LEAD NVY GUIDANT PUERTO RICO BV 4063

    Patients

    Seq Age Sex Outcome Treatment
    1