BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREEPI

    MDR report key: 4171401 · Received October 14, 2014

    Report

    Report Number
    2182208-2014-03108
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: ADSR01 IPG, IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE EMERGENCY ROOM WHERE THE DEVICE WAS NOTED TO BE AT ELECTIVE REPLACEMENT INDICATOR (ERI). THE PATIENT WAS ADMITTED AND SCHEDULED FOR DEVICE REPLACEMENT. THE PHYSICIAN ALSO ELECTED TO REPLACE THE RIGHT VENTRICULAR (RV) LEAD DUE TO RISING THRESHOLDS. UPON INTERROGATION OF THE DEVICE AT THE REPLACEMENT PROCEDURE THE DEVICE WAS NOT AT ERI. THE REPRESENTATIVE WAS ABLE TO REPROGRAM THE PACING MODE AND LOWER RATE. TECHNICAL REVIEW REVEALED THE DEVICE INAPPROPRIATELY TRIGGERED A MEASUREMENT LOCK-UP ERI. THIS ISSUE DOES NOT IMPACT BATTERY LONGEVITY AND DOES NOT REQUIRE DEVICE EXPLANT. THE DEVICE WAS EXPLANTED AND THE LEAD WAS 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
    650508 CAPSUREEPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 4965-25

    Patients

    Seq Age Sex Outcome Treatment
    1 00006 YR Hospitalization| R 505DA20 MECHANICAL HEART VALVE