BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA

    MDR report key: 2864706 · Received December 10, 2012

    Report

    Report Number
    6000144-2012-06648
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    October 30, 2012
    Report Date
    December 17, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DXY
    PMA / PMN Number
    P980035/S014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOR USE BY USER FACILITY/IMPORTER(DEVICES ONLY): THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. A 4568 IMPLANTABLE PACING LEAD, 2004-06-14. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4)-THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYZED. THE DEVICE EXPERIENCED NORMAL DEPLETION AND MET EXPECTED LONGEVITY.

    Additional Manufacturer Narrative · 1

    FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S DEVICE "SLID[ ] INTO [THE] AXILLA" AND ERODED. THE DEVICE AND LEADS WERE EXTRACTED. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE DEVICE SYSTEM WILL BE REPLACED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC MED REL MEDTRONIC PUERTO RICO KDR901

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R 4024 IMPLANTABLE PACING LEAD