BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 5424142 · Received February 9, 2016

    Report

    Report Number
    2649622-2016-01063
    Event Type
    Injury
    Date Received
    February 9, 2016
    Date of Event
    December 31, 2015
    Report Date
    December 31, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY PLACING THE RIGHT ATRIAL (RA) LEAD. AT PRE-DISCHARGE EVALUATION (PDE), THE RA LEAD EXHIBITED HIGH THRESHOLDS AND NO CAPTURE. THE LEAD WAS TURNED OFF AND WAS LATER EXPLANTED AND REPLACED. THE PHYSICIAN ALSO HAD DIFFICULTY PLACING THE RIGHT VENTRICULAR (RV) LEAD. AT PDE IT WAS DISCOVERED THAT THE RV LEAD HAD DISLODGED. 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
    81710 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 457445

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R