BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 3202409 · Received July 2, 2013

    Report

    Report Number
    2182208-2013-01865
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: ADDRL1, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013. PRODUCT ID: 4965-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, EXPLANTED: (B)(6) 2013. PRODUCT ID: 2292. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE THE VENTRICULAR LEAD BEGAN TO HAVE HIGH THRESHOLDS AND VARYING IMPEDANCE READINGS. IT WAS ALSO NOTED THAT THE ATRIAL LEAD IMPEDANCE READINGS WERE VARYING DURING THE PROCEDURE. THE ANALYZER CABLES WERE CHANGED OUT AND THE VARYING IMPEDANCE CONTINUED. AFTER THE LEADS WERE CONNECTED TO THE NEW DEVICE THE IMPEDANCE READING WERE WITHIN NORMAL RANGE. THE PHYSICIAN LATER DECIDED TO CAP AND REPLACE BOTH THE VENTRICULAR AND ATRIAL LEADS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303043 CAPSURE EPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 4965-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR Hospitalization| R