BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2790959 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01589
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 9, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. LOWER CASE, BOTH BAIL COVERS, AND RING COVER ARE BROKEN. ATRIAL OUTPUT CONNECTOR IS OCCLUDED BY A BROKEN PIN STUCK INSIDE. BATTERY CONTACTS ARE COMPRESSED. THE RING IS BENT. KEYBOARD IS SCRATCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ATRIAL NEGATIVE PORT ON THE EPG (EXTERNAL PULSE GENERATOR) WILL NOT HOLD THE CABLE. THE ATRIAL POSITIVE PORT IS ALSO LOOSE. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    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 5433A INSTRUMENT CABLE| 5433V INSTRUMENT CABLE