BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 5559407 · Received April 7, 2016

    Report

    Report Number
    2649622-2016-03802
    Event Type
    Injury
    Date Received
    April 7, 2016
    Date of Event
    January 27, 2016
    Report Date
    January 27, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED THAT ON (B)(6) 2015 THE MINIMUM RIGHT VENTRICULAR PACING IMPEDANCE MEASURED 216 OHMS. THE AVERAGE RIGHT VENTRICULAR PACING IMPEDANCE RANGED BETWEEN 231-275 OHMS. SINCE (B)(6) 2015 SHORT CIRCUIT PACE COUNT IS 16777215 AND NON-PHYSIOLOGICAL SENSE COUNT IS 445 WITH 4488 SUCCESSFUL PACES. CONCOMITANT PRODUCTS: 4524-45 LEAD, IMPLANTED (B)(6) 2001. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SYNCOPAL EPISODE. NOISE WAS NOTED ON THE RIGHT VENTRICULAR CHANNEL. THE LEAD HAD SWITCHED TO UNIPOLAR SOME TIME AGO. AT A DEVICE CHECK, THE RIGHT VENTRICULAR LEAD SENSE POLARITY WAS REPROGRAMMED BACK TO BIPOLAR. THE PACING POLARITY REMAINED UNIPOLAR WHICH CAUSED LOSS OF CAPTURE. THE LEAD WAS REPROGRAMMED BACK TO UNIPOLAR SENSING. THE LEAD ALSO HAD LOW IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211285 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 402452

    Patients

    Seq Age Sex Outcome Treatment
    1 00093 YR Hospitalization| L| R