BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3153602 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06124
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT: VEDR01 IMPLANTABLE PULSE GENERATOR (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMMEDIATELY POST-OP, THE MONITOR SHOWED LOSS OF CAPTURE ON THE VENTRICULAR LEAD. DURING DEVICE CHECK, SENSING NUMBERS AND THRESHOLDS ON THE LEAD VARIED WILDLY. THE PHYSICIAN DECIDED TO RE-OPEN AND REPOSITION THE LEAD. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254144 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407458

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R 4574 IMPLANTABLE PACING LEAD