BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 4832628 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-07465
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 17, 2015
    Report Date
    March 17, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 RIGHT ATRIAL (RA) LEAD HAD HIGH IMPEDANCE AND A CONFIRMED FRACTURE. THE LEAD WAS CAPPED AND REPLACED. IT WAS ALSO REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ADMINISTERED INAPPROPRIATE SHOCKS. THE ICD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373867 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 457453

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| R (B)(4) LEAD