BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 8125481 · Received December 3, 2018

    Report

    Report Number
    2649622-2018-19761
    Event Type
    Injury
    Date Received
    December 3, 2018
    Date of Event
    December 1, 2013
    Report Date
    December 3, 2018
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: SESR01 IPG IMPLANTED: UNKNOWN DATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HEART RATE OF APPROXIMATELY 40 BEATS PER MINUTE. THERE WAS SUSPECTED ATRIAL LEAD DAMA GE, AND UNDERSENSING AND NOISE WERE OBSERVED. PER THE PHYSICIAN'S MEDICAL JUDGEMENT, THE LEAD REMAINS IN USE AND WILL BE MONITORED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966384 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4524

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention