BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3990666 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08559
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH THRESHOLDS AND INTERMITTENT CAPTURE WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) PACING LEAD AS WELL AS R-WAVE UNDERSENSING. X-RAY EXAMINATION REVEALED THAT THE LEAD HAD MOVED. THE PHYSICIAN WAS UNABLE TO SUCCESSFULLY REPOSITION AND FIXATE THE EXISTING LEAD AT THE DESIRED LOCATION SO AN ACTIVE FIXATION STYLE LEAD WAS REQUIRED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468364 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407452

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R ADSR01 DEVICE