BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 4161246 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11596
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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: 5076-45 LEAD IMPLANTED: 2002-(B)(6); 5076-52 LEAD IMPLANTED: 2002-(B)(6); 5524M-53 LEAD IMPLANTED: 1998-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXTRACTED. THE CAPPED RIGHT VENTRICULAR (RV) LEAD BROKE DURING LASER EXTRACTION. THE ACTIVE LEADS AND REMAINING CAPPED LEAD ARE SCHEDULED TO BE EXTRACTED VIA STERNOTOMY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637625 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5024M-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention A2DR01 IPG