BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 3113480 · Received May 15, 2013

    Report

    Report Number
    2182208-2013-01132
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. (B)(4) IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTED (B)(6) 2011; 4965 IMPLANTABLE PACING LEAD IMPLANTED (B)(6) 2005.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT VENTRICULAR LEAD HAD A POSSIBLE IMPEDANCE INCREASE. THE LEAD IS FURTHER REPORTED TO FAIL TO CAPTURE WHEN THE PATIENT STRETCHES AND RAISES ARMS. THE PATIENT IS REPORTED TO BE SYMPTOMATIC WITH FAILURE TO CAPTURE. INCREASING THE PROGRAMMED OUTPUT RESULTED IN MUSCLE/POCKET STIMULATION. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214841 CAPSURE EPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN RICE CREEK MFG 4965-25

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Hospitalization| R