BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3153749 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01466
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    April 1, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 PRODUCTS: 670100, ANNULOPLASTY BAND, (B)(6) 2010; 6935, IMPLANTABLE TACHY LEAD, (B)(6) 2011; 5076, IMPLANTABLE PACING LEAD, (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD INCREASED THRESHOLD AND HIGH IMPEDANCE. THEREFORE THE LV LEAD WAS CAPPED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255077 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN RICE CREEK MFG 4965-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Hospitalization| R D224TRK IMPLANTABLE PACEMAKER CARDIO/DEFIB