BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 2955450 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01419
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    November 28, 2012
    Report Date
    December 7, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. 4024 IMPLANTABLE PACING LEAD 1996 (B)(6). (B)(4). LEAD REMAINS IN USE.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD TRIGGERED A LEAD WARNING FOR LOW IMPEDANCE. THE LEAD IS STILL 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
    59953 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4524-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR (B)(4) IMPLANTABLE PULSE GENERATOR