BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 1992198 · Received February 15, 2011

    Report

    Report Number
    2183613-2011-00058
    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
    MN, US
    Reporter Occupation
    OTHER

    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. WITHOUT A LOT NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED FOR THE MODEL 5433V. EVALUATION SUMMARY: (B)(4): ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. THE UPPER AND LOWER CASES AND SIDE BAIL COVERS WERE FOUND TO BE BROKEN. VISUAL INSPECTION OF THE CABLE FOUND ONE OF THE FASTENERS TO BE BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATH LAB HAD PROBLEMS WITH THIS UNIT ON TWO OCCASIONS, WITH TWO SEPARATE PATIENTS. THERE WAS NO OUTPUT AT MAXIMUM SETTINGS. THEY STATED THE "PACER SPIKES DISAPPEARED," AND CAPTURE WAS LOST. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE MODEL 5433V WAS RETURNED WITH THE EPG (EXTERNAL PULSE GENERATOR) AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATH LAB HAD PROBLEMS WITH THIS UNIT ON TWO OCCASIONS, WITH TWO SEPARATE PATIENTS. THERE WAS NO OUTPUT AT MAXIMUM SETTINGS. THEY STATED THE "PACER SPIKES DISAPPEARED," AND CAPTURE WAS LOST. NO PATIENT COMPLICATIONS WERE 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 MILACA INC. 5388 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(4) INSTRUMENT CABLE