BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2864966 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17669
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 30, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061/S012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON INTERROGATION THE RIGHT ATRIAL (RA) LEAD SHOWED OVERSENSING OF NOISE ON ATRIAL HIGH RATE EPISODES. THE NOISE WAS REPRODUCIBLE DURING ISOMETRIC EXERCISES. THE NOISE APPEARED TO BE MYOPOTENTIAL ALTHOUGH THE LEAD WAS PROGRAMMED BIPOLAR. THE SENSITIVITY WAS ADJUSTED WITH NO FURTHER SENSING ISSUES. THE LEAD REMAINS IN USE WITH CONTINUED MONITORING. 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 4524-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention ADDR01 IMPLANTABLE PULSE GENERATOR (IPG)