BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 8925096 · Received August 23, 2019

    Report

    Report Number
    2649622-2019-15077
    Event Type
    Injury
    Date Received
    August 23, 2019
    Date of Event
    June 8, 2019
    Report Date
    August 23, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 4024-58 LEAD, IMPLANTED (B)(6) 1996; 5076-45 LEAD, IMPLANTED (B)96) 2001; ADDRL1 IPG, IMPLANTED (B)(6) 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH IMPEDANCE AND RISING THRESHOLDS WHICH RESULTED IN A POLARITY SWITCH. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE AND NO CAPTURE. BOTH LEADS WERE 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
    720103 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024-58

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R 4004M58 LEAD