BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2791624 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01736
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 12, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 COULD NOT CONFIRM THE REPORTED EVENT. NO LOOSE PART WAS FOUND IN THE DEVICE. CAPACITOR IS MISSING FROM THE MAIN PRINTED CIRCUIT BOARD ASSEMBLY. LOWER CASE AND BOTH BAIL COVERS ARE MISSING. ONE PRINTED CIRCUIT BOARD FLEX IS CREASED. BATTERY CONTACTS ARE COMPRESSED. THE RING IS BENT. KEYBOARD WINDOW IS SCRATCHED. SERIAL NUMBER LABEL IS TORN.

    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 MANUFACTURING DATE. EVALUATION SUMMARY: (B)(6). ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. NO LOOSE PART WAS FOUND IN THE DEVICE. CAPACITOR IS MISSING FROM THE MAIN PRINTED CIRCUIT BOARD ASSEMBLY. LOWER CASE AND BOTH BAIL COVERS ARE MISSING. ONE PRINTED CIRCUIT BOARD FLEX IS CREASED. BATTERY CONTACTS ARE COMPRESSED. THE RING IS BENT. KEYBOARD WINDOW IS SCRATCHED. SERIAL NUMBER LABEL IS TORN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD A COMPONENT LOOSE INSIDE IT AND IT WAS RETURNED FOR SERVICE. FOLLOW-UP DETERMINED THAT IT WAS FOUND DURING ROUTINE TESTING AND 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