BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA+ C SERIES DR

    MDR report key: 2812330 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02532
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    November 12, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P990001/S14
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND WE ALSO RECEIVED PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS FOUND NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EARLY BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA+ C SERIES DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. C60A1

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 1646T COMPETITOR IMPLANTABLE PACING LEAD| 1480T COMPETITOR IMPLANTABLE PACING LEAD