BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERA-I DR

    MDR report key: 1792671 · Received August 11, 2010

    Report

    Report Number
    2647346-2010-00361
    Event Type
    Injury
    Date Received
    August 11, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S37
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) BATTERY DEPLETION-NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD THE ELECTIVE REPLACEMENT INDICATOR ACTIVATED AS WELL THE DEVICE SHOWED A POWER ON RESET. THE DEVICE REMAINS IMPLANTED AND IN USE AND WILL BE EVALUATED UPON EXPLANTATION AND RETURN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD THE ELECTIVE REPLACEMENT INDICATOR ACTIVATED AS WELL THE DEVICE SHOWED A POWER ON RESET. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE HAS BEEN EXPLANTED AND REPLACED. NO 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 89 YR Required Intervention (B)(4) IMPLANTABLE PACING LEAD| 4068 IMPLANTABLE PACING LEAD