BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 1864987 · Received October 12, 2010

    Report

    Report Number
    2182208-2010-00776
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    July 29, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTE
    PMA / PMN Number
    NONE
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    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. EVALUATION SUMMARY: (B)(4): ANALYSIS CONFIRMED THE SENSITIVITY WAS OUT OF SPECIFICATION. THIS MODEL IS UNREPAIRABLE BECAUSE IT IS OBSOLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT IS UNDERSENSING. THE DEVICE MODEL IS OBSOLETE, A NEWER MODEL WILL BE USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EPG (EXTERNAL PULSE GENERATOR) WAS UNDERSENSING. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE EXTERNAL PULSE GENERATOR DTE MEDTRONIC, INC. 5375 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other