BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 3153399 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01425
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 22, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. PRODUCT: 4968 IMPLANTABLE PACING LEAD (B)(6) 2004; ADDRL1 IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW DAYS AFTER A ROUTINE DEVICE CHANGE, THE PATIENT WAS EXPERIENCING MUSCLE STIMULATION AS THE RIGHT ATRIAL (RA) LEAD WAS SET TO A HIGH THRESHOLD. THE RIGHT VENTRICULAR (RV) LEAD APPEARED HIGH IN BIPOLAR CONFIGURATION, AND WITHIN NORMAL RANGE IN UNIPOLAR. WHEN THE LEAD WAS CHANGED BACK TO BIPOLAR, THE THRESHOLDS WERE BACK TO WHAT THEY HAD BEEN PRIOR TO THE CHANGEOUT. BOTH RA AND RV LEADS WERE REPROGRAMMED AND REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258907 ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4968-60

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR Required Intervention