BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2051196 · Received April 12, 2011

    Report

    Report Number
    2182208-2011-00520
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    January 25, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT VENTRICULAR LEAD IMPEDENCE HAS INCREASED OVER THE COURSE OF TWO WEEKS. RECORDS INDICATE THAT THE LEAD REMAINS IN USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. FURTHER INFORMATION RECEIVED INDICATED THAT THE LEFT VENTRICULAR LEAD FRACTURED. THE LEAD WAS CAPPED AND REPLACED. DURING THE LEAD REVISION, THE THRESHOLDS ON THE PREVIOUSLY CAPPED LEFT VENTRICULAR LEAD WERE NOTED TO BE HIGH ENOUGH. THE PREVIOUSLY CAPPED LV LEAD WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT VENTRICULAR LEAD IMPEDENCE HAS INCREASED OVER THE COURSE OF TWO WEEKS. RECORDS INDICATE THAT THE LEAD REMAINS IN USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4965 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD