BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 2132013 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00948
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. EVALUATION SUMMARY: (B)(4) ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. THE MAIN PRINTED CIRCUIT BOARD FOUND OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE AUTO SHUT DOWN. FOLLOWUP INFORMATION INDICATES THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THE ICU NURSES NOTICED ON THEIR TELEMETRY THAT THE HEART RATE WAS SLOW. THAT'S WHEN THEY REALIZED UNIT WAS OFF. THE BATTERY IN THE UNIT WAS FOUND TO BE VERY HOT. EVEN AFTER REPLACING WITH A NEW BATTERY, THE UNIT COULD NOT BE TURN ON. THE DEVICE WAS REPLACED WITH ANOTHER UNIT. 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 ASKU EXTERNAL PULSE GENERATOR DTE MEDTRONIC, INC. 5388 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention