BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREEPI

    MDR report key: 3781432 · Received April 30, 2014

    Report

    Report Number
    2182208-2014-01180
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    November 14, 2003
    Report Date
    April 4, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 MEDICAL PRODUCTS: A 4968-35 LEAD, IMPLANTED: (B)(6) 2003. A 6937A-52 LEAD, IMPLANTED: (B)(6) 2003. A 6996SQ-58 LEAD, IMPLANTED: (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD FRACTURES ARE SUSPECTED. IT WAS FURTHER REPORTED THAT THE PATIENT'S FAMILY NOTED THAT THE LEADS WERE FRACTURED SHORTLY AFTER IMPLANT AND DEVICE THERAPIES HAD BEEN DISABLED. THE LEADS REMAIN IMPLANTED AND OUT OF SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260169 CAPSUREEPI ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4968-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 MO Required Intervention 7230CX ICD