BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA+ T SERIES DR

    MDR report key: 1718075 · Received June 10, 2010

    Report

    Report Number
    6000094-2010-01288
    Event Type
    Injury
    Date Received
    June 10, 2010
    Date of Event
    March 10, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. CORRECTION: DEVICE CODE CHANGED. EVALUATION SUMMARY: (B)(4) ANALYSIS CONFIRMED NO LEAD IMPEDANCE MEASUREMENTS WERE POSSIBLE. THE CONDITION DISAPPEARED DURING FURTHER ANALYSIS. THE ROOT CAUSE COULD NOT BE DETERMINED. DEVICE MODEL T70A1 IS NOT APPROVED IN THE US; HOWEVER IT IS SIMILAR TO US DEVICES APPROVED UNDER PMA: P1010031.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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. DEVICE MODEL T70A1 IS NOT APPROVED IN THE US; HOWEVER IT IS SIMILAR TO US DEVICES APPROVED UNDER PMA: P1010031.

    Description of Event or Problem · 1

    IT WAS REPORTED IMPLANTABLE PULSE GENERATOR (IPG) FAILED IN PERFORMING LEAD IMPEDANCE THRESHOLD AND SENSE TESTS DURING ROUTINE FOLLOW-UP. CONSEQUENTLY, THE DEVICE WAS EXCISED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) FAILED IN PERFORMING LEAD, IMPEDANCE THRESHOLD AND SENSE TESTING. THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA+ T SERIES DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. T70A1 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention