BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREEPI

    MDR report key: 3971926 · Received July 31, 2014

    Report

    Report Number
    2182208-2014-01880
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 PRODUCT: 4965-35 LEAD, IMPLANTED: (B)(6) 1999.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD HAD HIGH THRESHOLDS. THE LEAD WAS CAPPED. IT WAS FURTHER REPORTED THE REPLACEMENT LEAD WAS UNABLE TO OBTAIN GOOD THRESHOLDS AFTER THREE DIFFERENT POSITIONS WERE TRIED. THE LEAD WAS REMOVED,DISCARDED BY THE HOSPITAL 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
    446955 CAPSUREEPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 4965-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR Hospitalization| R ADDR01 IPG