BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 5121331 · Received October 2, 2015

    Report

    Report Number
    2649622-2015-12821
    Event Type
    Injury
    Date Received
    October 2, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 17, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. CONCOMITANT MEDICAL PRODUCTS: (B)(4) ICD, IMPLANTED: (B)(6) 2012; (B)(4) LEAD IMPLANTED: 2005-09-12. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEAD WAS CAPPED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP APPOINTMENT, CAPTURE MANAGEMENT SHOWED AN INCREASE IN THRESHOLDS ON THE RIGHT ATRIAL (RA) LEAD, AND THERE WAS ALSO LOW PACING IMPEDANCE. A WARNING HAD TRIGGERED TWO MONTHS AGO. THE PATIENT HAD SMALL P WAVE SENSING AND THE PROGRAMMING WAS ADJUSTED SO UNDERSENSING WAS NOT OCCURRING. 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
    653251 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4524-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R