BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 4163459 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02973
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    April 15, 2011
    Report Date
    July 30, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. THE LEAD WAS DISCARDED AND THE MODEL/SERIAL NUMBER IS UNKNOWN. WITHOUT A DEVICE MODEL AND SERIAL NUMBER THE PMA/510(K), MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TOTAL OF 4 INFECTIONS HAVE OCCURRED SINCE THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS IMPLANTED AT A FREQUENCY OF ONE INFECTION PER YEAR. THE TREATMENT FOR EACH INFECTION WAS MOVING THE IPG FROM THE LEFT SIDE TO THE RIGHT SIDE AND THEN FROM THE RIGHT SIDE TO THE LEFT SIDE WHEN THE NEXT INFECTION OCCURRED. WITH THE MOST RECENT INFECTION THE IPG SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640056 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R MEDTRONIC LEAD, SD303U IPG