BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITATRON DA+ T-SERIES DR

    MDR report key: 3992298 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01985
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Removal / Correction Number
    Z-1000-2007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 INFORMATION INDICATED THAT THE BATTERY STATUS SHOWS A USED BATTERY CAPACITY OF 1563.7 MAH. THE DEVICE BATTERY LONGEVITY WAS NOT CALCULATED DUE TO THE PROGRAMMER SOFTWARE NOT EXPECTING A USED BATTERY CAPACITY GREATER THAN THE ASSUMED MAXIMUM DELIVERABLE BATTERY CAPACITY OF 1550 MAH.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION.  BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. CONCOMITANT PRODUCTS: (B)(4) LEAD IMPLANTED: 2005 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT CORRECTLY DISPLAY THE BATTERY LONGEVITY UPON INTERROGATION. IT WAS DETERMINED THAT THE USED BATTERY CAPACITY WAS GREATER THAN THE PROGRAMMER SOFTWARE COULD CALCULATE, AND THE DEVICE WAS APPROACHING ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471843 VITATRON DA+ T-SERIES DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY IPG MFG SWITZERLAND T60A1B

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR (B)(4) LEAD