BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 4830735 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05901
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 8, 2015
    Report Date
    April 8, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. CONCOMITANT PRODUCT: 457445 LEAD, IMPLANTED: (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE DEVICE REPLACEMENT, THE PHYSICIAN DECIDED TO EXPLANT THE RIGHT VENTRICULAR (RV) LEAD DUE TO HIGH THRESHOLDS. WHILE EXPLANTING THE RV LEAD, THE ATRIAL DISLODGED. BOTH LEADS WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380507 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407452

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Hospitalization| R ADDR01 IPG