BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY SR

    MDR report key: 2953687 · Received February 9, 2013

    Report

    Report Number
    2647346-2013-00014
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    December 5, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    DXY
    PMA / PMN Number
    P890003
    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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    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 PATIENT WAS LOST TO FOLLOW UP FOR OVER ONE YEAR. WHEN THE DEVICE WAS CHECKED IT WAS NON-FUNCTIONAL AND IT WAS NOT ABLE TO BE INTERROGATED. IT WAS NOTED THAT THE DEVICE WAS MOST LIKELY AT END OF LIFE. 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
    57128 PRODIGY SR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MDT PUERTO RICO OPERATIONS CO, MED REL 8160B

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 4068 IMPLANTABLE PACING LEAD