BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 4160949 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11696
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 2, 2014
    Report Date
    July 25, 2022
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 MEDICAL PRODUCTS: 4592-53, LEAD, IMPLANTED: (B)(6) 1999. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN AND PALPITATIONS. THE RIGHT ATRIAL (RA) LEAD WAS NOTED TO HAVE BOTH OVERSENSING AND UNDERSENSING. THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED TO HAVE OVERSENSING. BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642314 CAPSURE SP PERMANENT PACEMAKER ELECTRODE DTB MPRI 4024-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Male ADDR01 IPG| ADDR01 IPG