BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERA-I DR

    MDR report key: 1861669 · Received October 8, 2010

    Report

    Report Number
    2647346-2010-00587
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    October 23, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S37
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR, THE BATTERY VOLTAGE WAS AT 2.58 VOLTS AND IMPEDANCE AT 29,000 OHMS. THE PATIENT REPORTED DIZZINESS DURING INTERROGATION. THE DEVICE REMAINS IN USE. 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 THERA-I DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. 7960IB ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR Other 5032 IMPLANTABLE PACING LEAD