BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2811856 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01897
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 12, 2012
    Report Date
    November 27, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE HEART LEAD FLEX WAS OUT OF SPECIFICATION DUE TO A FAULTY DIODE ON THE VENTRICULAR SIDE. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN, THE RING COVER WAS BROKEN, TWO SIDE BAIL COVERS WERE MISSING, THE RING AND TWO SIDE BAILS WERE MISSING, THE LEAD FLEX COVER AND BATTERY DRAWER WERE CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED AND THE KEYBOARD PAD WAS COSMETICALLY DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BIOMED WAS DOING A FUNCTIONAL TEST OF THE DEVICE AND FOUND THAT SEVERAL PARAMETERS ARE OUT OF SPECIFICATION. THE DEVICE HAS BEEN RETURNED FOR CHECKOUT/REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BIOMED WAS DOING A FUNCTIONAL TEST OF THE DEVICE AND FOUND THAT SEVERAL PARAMETERS ARE OUT OF SPECIFICATION. THE DEVICE IS BEING RETURNED FOR CHECKOUT/REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BIOMED WAS DOING A FUNCTIONAL TEST OF THE DEVICE AND FOUND THAT SEVERAL PARAMETERS ARE OUT OF SPECIFICATION. THE DEVICE HAS BEEN RETURNED FOR CHECKOUT/REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Other