BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 2952524 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00189
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 16, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    K940703
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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: 2250 COMPETITOR IMPLANTABLE PULSE GENERATOR (IPG). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOLLOWUP RECORDS NOTED POSSIBLE NOISE ON THE RIGHT ATRIAL (RA) LEAD. IT WAS ALSO REPORTED THAT DURING A ROUTINE DEVICE CHANGEOUT, IT WAS NOTED THAT THE RA LEAD HAD A SMALL NICK IN THE LEAD INSULATION AT THE PROXIMAL END. FLEXING OF THE LEAD RESULTED IN NOISE ON THE ATRIAL ELECTROGRAM THROUGH THE ANALYZER. THE LEAD WAS REPAIRED WITH MEDICAL ADHESIVE AND AN INSULATION SLEEVE AND REMAINS IN USE. NO FURTHER NOISE WAS NOTED POST REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57298 NONE ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4558M

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R BT46 COMPETITOR IMPLANTABLE PACING LEAD