BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 2810989 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01861
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 28, 2012
    Report Date
    December 12, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT OF CONTAMINATION. HOWEVER THE DEVICE WAS RETURNED TO THE MANUFACTURER IN PIECES AND WAS DETERMINED TO BE UNREPAIRABLE DUE TO EXTENSIVE DAMAGE.

    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE NEEDS SOME MAJOR REPAIR WORK. FURTHER INFORMATION REPORTED THE DEVICE WAS FOUND IN THE SURGERY AREA, AND IT WAS MARKED AS "BROKEN." THE DEVICE HAD BLOOD STAINS EXTERNALLY, AND IT WAS NOTICED THERE WAS SOME BLOOD IN THE BATTERY COMPARTMENT AREA. THE DEVICE IS BEING RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE NEEDS SOME MAJOR REPAIR WORK. FURTHER INFORMATION REPORTED THE DEVICE WAS FOUND IN THE SURGERY AREA, AND IT WAS MARKED AS "BROKEN". THE DEVICE HAD BLOOD STAINS EXTERNALLY, AND IT WAS NOTICED THERE WAS SOME BLOOD IN THE BATTERY COMPARTMENT AREA. THE DEVICE IS BEING RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE NEEDS SOME MAJOR REPAIR WORK. FURTHER INFORMATION REPORTED THE DEVICE WAS FOUND IN THE SURGERY AREA, AND IT WAS MARKED AS "BROKEN". THE DEVICE HAD BLOOD STAINS EXTERNALLY, AND IT WAS NOTICED THERE WAS SOME BLOOD IN THE BATTERY COMPARTMENT AREA. THE DEVICE IS BEING RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other