BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 1992197 · Received February 15, 2011

    Report

    Report Number
    2183613-2011-00057
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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): ANALYSIS COULD NOT DUPLICATE CUSTOMER COMMENTS. ANALYSIS DID FIND THAT THE UPPER AND LOWER CASES WERE BROKEN AND CORRODED, THE BATTERY RELEASE AND LIQUID CRYSTAL DISPLAY (LCD) WERE CONTAMINATED, THE RING AND SIDE BAIL COVERS AND RING AND SIDE BAILS WERE MISSING, THE LEAD FLEX COVER WAS BROKEN AND CORRODED, THE BATTERY CONTACTS WERE COMPRESSED AND CONTAMINATED, THE BATTERY DRAWER WAS BROKEN AND CONTAMINATED, AND THE BATTERY FLEX AND HEART LEAD FLEX WERE CORRODED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS. THE CHANGE IS REFLECTED IN THIS REPORT. EVALUATION SUMMARY: (B)(4): ANALYSIS COULD NOT DUPLICATE CUSTOMER COMMENTS. ANALYSIS DID FIND THAT THE UPPER AND LOWER CASES WERE BROKEN AND CORRODED, THE BATTERY RELEASE AND LIQUID CRYSTAL DISPLAY (LCD) WERE CONTAMINATED, THE RING AND SIDE BAIL COVERS AND RING AND SIDE BAILS WERE MISSING, THE LEAD FLEX COVER WAS BROKEN AND CORRODED, THE BATTERY CONTACTS WERE COMPRESSED AND CONTAMINATED, THE BATTERY DRAWER WAS BROKEN AND CONTAMINATED, AND THE BATTERY FLEX AND HEART LEAD FLEX WERE CORRODED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE TURNED OFF WHILE IN USE ON A PATIENT. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5388 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other