BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2790850 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01588
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 8, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. EVALUATION SUMMARY: (B)(4). ANALYSIS CONFIRMED THE REPORTED EVENT. VENTRICLE CONNECTOR WAS NOT FULLY INSERTED INTO THE FLEX TAPE CONNECTOR. BOTH PRINTED CIRCUIT BOARD FLEX'S ARE CREASED.

    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 CONFIRMED THE REPORTED EVENT. VENTRICLE CONNECTOR WAS NOT FULLY INSERTED INTO THE FLEX TAPE CONNECTOR. BOTH PRINTED CIRCUIT BOARD FLEX'S ARE CREASED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR OUTPUT ON THE EXTERNAL PULSE GENERATOR WAS NOT FUNCTIONING. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT IMPACT 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