BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 3153788 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06216
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT MEDICAL PRODUCTS: E2DR21 IMPLANTABLE PULSE GENERATOR: (B)(6) 2007. 4024 IMPLANTABLE PACING LEAD: (B)(6) 1996. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE DEVICE REPLACEMENT, THE RIGHT ATRIAL (RA) LEAD HAD BEEN SET TO UNIPOLAR DUE TO LOW IMPEDANCE, THE UNIPOLAR IMPEDANCE WAS HIGHER THAN THE BIPOLAR IMPEDANCE AND THERE WERE MANY EPISODES IN THE RECORD TO SUGGEST OVERSENSING OF MYOGENIC POTENTIAL DUE TO THE UNIPOLAR CONFIGURATION. THE RA LEAD WAS REPROGRAMMED TO THE BIPOLAR CONFIGURATION AND ELECTRICAL MEASUREMENTS WERE TESTED AND OVERSENSING COULD NOT BE CONFIRMED. DUE TO A SUSPECTED VEIN OCCLUSION IT WAS ELECTED TO LEAVE THE RA LEAD PROGRAMMED TO BIPOLAR, RATHER THAN IMPLANT A NEW RA LEAD. THE RA LEAD 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
    255385 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4524-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention