BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE EPI

    MDR report key: 2143426 · Received June 29, 2011

    Report

    Report Number
    2182208-2011-01053
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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 THERE WAS A LEAD WARNING FOR LOW IMPEDANCE AND THE TWO RIGHT VENTRICULAR LEADS, WHICH HAD BEEN ADAPTED TO ALLOW FOR BIPOLAR PROGRAMMING, HAD A POLARITY SWITCH FROM BIPOLAR TO UNIPOLAR. THE LEADS REMAIN IN USE IN A UNIPOLAR CONFIGURATION. 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. 4965 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other (B)(4) IMPLANTABLE LEAD ADAPTOR| 4965 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR