BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITATRON DA+ C-SERIES DR

    MDR report key: 2952371 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00108
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 16, 2012
    Manufacturer
    VITATRON MEDICAL B.V.
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. 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 SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY SHOWED THE BATTERY INDICATOR SIGNIFYING THAT IT WAS TIME FOR DEVICE REPLACEMENT. ON 2013-(B)(4). THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED. THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) WITH LIMITED INTERROGATION FUNCTION AVAILABLE. POSSIBLE PREMATURE BATTERY DEPLETION WAS QUESTIONED BY THE CUSTOMER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55554 VITATRON DA+ C-SERIES DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY VITATRON MEDICAL B.V. C50A1

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R