BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITATRON DA+ C-SERIES DR

    MDR report key: 3151756 · Received June 7, 2013

    Report

    Report Number
    9614453-2013-01087
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 4, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Removal / Correction Number
    Z-0999-2007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. (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 IMPLANTABLE PULSE GENERATOR (IPG) REPEATEDLY SHOWED THE SAME ESTIMATED REMAINING BATTERY LIFE OVER AN EXTENDED PERIOD OF TIME. THE IPG WAS EXPLANTED AND REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OFTHIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252417 VITATRON DA+ C-SERIES DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY IPG MFG SWITZERLAND C60A1B

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R 1388TX2 COMPETITOR IMPLANTABLE PACING LEAD