BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2864882 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17597
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089/S015
    Adverse Event
    Yes
    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. ADD'L DEVICE: 6949 IMPLANTABLE TACHY LEAD (B)(6) 2005. (B)(4). LEAD REMAINS AT LEAST PARTIALLY IN THE BODY.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE EXPLANT PROCEDURE, IT WAS NOTED THAT THE LEAD INSULATION WAS FRACTURED NEAR THE SUTURE SLEEVE. THE LEAD WAS PARTIALLY 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
    1 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5024M

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R 7232CX IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD)