BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

    MDR report key: 2955360 · Received February 11, 2013

    Report

    Report Number
    2182208-2013-00352
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 5, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 : ADDR01 IMPLANTABLE PACEMAKER: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EPICARDIAL RIGHT ATRIAL LEAD IMPEDANCE HAD INCREASED AND WAS NOW HIGH, THE LEAD WAS UNDERSENSING P WAVES, AND IT NOT CAPTURING. IT WAS ALSO REPORTED THAT THE EPICARDIAL RIGHT VENTRICULAR LEAD WAS OVERSENSING AND THE IMPEDANCE WAS VARYING FROM 300 OHMS TO 500 OHMS WHILE THE PATIENT WAS IN THE CLINIC. A TRANSVENOUS SYSTEM WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59146 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 00022 YR Hospitalization| R 4965 IMPLANTABLE PACING LEAD