BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA+ C SERIES DR

    MDR report key: 2790613 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15355
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED HIGH BATTERY IMPEDANCE AND COULOMB COUNTER CLAMPING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN INTERROGATION WAS INITIATED DURING ROUTINE DEVICE FOLLOW-UP, AN ERROR MESSAGE DISPLAYED INDICATING THERE WAS A "BATTERY OPERATION ERROR" AND THE "LONGEVITY & BATTERY FIGURES ARE NO LONGER CORRECT." IT WAS ALSO REPORTED THAT THE DEVICE HAD A (B)(4) SOFTWARE ERROR THAT WAS LIKELY NOT CLEARED AT OR PRIOR TO DEVICE IMPLANT. ADDITIONALLY, THE DEVICE HAS HIGH BATTERY IMPEDANCE. THE DEVICE IS BEING MONITORED AND REMAINS 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
    1 DA+ C SERIES DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC PUERTO RICO, INC. C70A3

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other