BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 1851237 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14112
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P950001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT FROM A MEDICAL PERSON THAT THIS PATIENT WAS IN THE HOSPITAL AND AN ELECTROCARDIOGRAM (EKG) SHOWED AN ATRIAL PACING SPIKE FOLLOWING BY A LONG PAUSE (400 MS), THEN AN INTRINISIC R-WAVE. THE CALLER STATED SOMETHING WAS WRONG WITH THE PACEMAKER AND SENT THE PATIENT TO THE CARDIOLOGY CLINIC TO BE SEEN. VENTRICULAR CAPTURE WAS 0.8V AT 0.5MS AND TODAY AT 1.6V AT 0.5MS SHOWING APVP, BUT SEEING A FUSION BEAT WITH NO LONG PAUSES. TECHNICAL SERVICES SUSPECTS LOSS OF CAPTURE AND FUSION. THE OUTPUTS WERE INCREASED. NO ADVERSE PATIENT EFFECTS WERE REPORTED, HOWEVER THE PATIENT DID MENTION SHE WASN'T FEELING WELL. ALL OTHER MEASUREMENTS WERE NORMAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening 1291| 4063| 4034| 1283