BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SENSE

    MDR report key: 2811671 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17128
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 8, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL SUBMISSION OF THIS REPORT FAILED TO PROCESS TO ESG AND CANNOT BE RECOVERED. THIS REPORT IS BEING RESUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE THERE WAS BLOOD IN THE DISTAL END OF THE LEAD, THERE WAS BLOOD ON THE DISTAL AND PROXIMAL CONDUCTOR (NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEAD HAD "BAD PARAMETER." THE LEAD WAS NOT USED AND ANOTHER LEAD WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEAD HAD "BAD PARAMETER." THE LEAD WAS NOT USED AND ANOTHER LEAD WAS USED TO COMPLETE THE PROCEDURE. 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 SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4074

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Other