BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE EPI

    MDR report key: 2130020 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00856
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 25, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 LEFT VENTRICULAR LEAD HAD BEEN PLACED AND CAPPED DURING A PRIOR OPEN HEART SURGERY. DURING A LATER UPGRADE FROM A SINGLE CHAMBER PACEMAKER TO A BI-VENTRICULAR PACEMAKER, THE LEFT VENTRICULAR LEAD WAS UNCAPPED FOR USE, AND SHOWED NO CAPTURE WHEN ATTACHED TO THE ANALYZER. THE LEAD WAS REPOSITIONED TO A NEW LOCATION AND REMAINS IN USE. 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 EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4968 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD