BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2865055 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17673
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 29, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P920039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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: 5076 IMPLANTABLE PACING LEAD, (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A "JERKING SENSATION" THAT WAS AFFECTING SPEECH. IT WAS NOTED THAT THE PHYSICIAN HAD SEEN SLIGHTLY HIGH IMPEDANCE, ALONG WITH HIGH THRESHOLDS ON RIGHT ATRIAL (RA) LEAD. THE RA LEAD WAS REPROGRAMMED AND REMAINS IN USE. THERE HAS NOT BEEN ANY FURTHER INFORMATION IF THIS PROGRAMMING RELIEVED THE JERKINESS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ADDR01 IMPLANTABLE PULSE GENERATOR (IPG)