BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2791375 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01593
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 10, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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. EVALUATION SUMMARY: (B)(4) ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. UPPER AND LOWER CASES AND BATTERY DRAWER ARE BROKEN. LCD (LIQUID CRYSTAL DISPLAY) IS OUT OF SPECIFICATION (GASKET SEEPING OUT). BATTERY RELEASE AND LEAD FLEX COVER ARE CONTAMINATED. TWO SIDE BAIL COVERS AND TWO SIDE BAILS ARE MISSING. BATTERY CONTACTS ARE COMPRESSED. KEYBOARD PAD HAS A COSMETIC ISSUE.

    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 CONFIRM THE REPORTED EVENT. UPPER AND LOWER CASES AND BATTERY DRAWER ARE BROKEN. LCD (LIQUID CRYSTAL DISPLAY) IS OUT OF SPECIFICATION (GASKET SEEPING OUT). BATTERY RELEASE AND LEAD FLEX COVER ARE CONTAMINATED. TWO SIDE BAIL COVERS AND TWO SIDE BAILS ARE MISSING. BATTERY CONTACTS ARE COMPRESSED. KEYBOARD PAD HAS A COSMETIC ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN ATRIAL PACING, THE EXTERNAL PULSE GENERATOR WOULD VENTRICULAR PACE WITH AAI. THE GENERATOR WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS OR INVOLVEMENT WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other