BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N'VISION

    MDR report key: 920876 · Received September 21, 2007

    Report

    Report Number
    2182207-2007-02821
    Event Type
    Injury
    Date Received
    September 21, 2007
    Report Date
    September 13, 2006
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED WHICH COVERS A 2-YEAR RETROSPECTIVE REVIEW OF REPORTED EVENTS INVOLVING CATHETERS AND EVENTS REPORTED BY CONSUMERS BETWEEN JANUARY 1, 2005 AND DECEMBER 31, 2006 (INCLUSIVE). THIS EXEMPTION WAS GRANTED TO SATISFY MEDTRONIC'S MDR OBLIGATIONS FOR ANY PREVIOUSLY UNREPORTED SERIOUS INJURY, DEATH AND MALFUNCTION EVENTS FOUND DURING THIS REVIEW. THIS MEDWATCH REPORT REPRESENTS 4 UNREPORTED SERIOUS INJURY EVENTS FOR MODEL 8840 (ALL PRODUCT CODE LKK). THIS TOTAL INCLUDES THE EVENT DESCRIBED IN THIS REPORT. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE PATIENT'S SPOUSE REPORTED THE PATIENT BEEN OVERDOSED TWICE IN THE PAST MONTH. THE FIRST TIME THE SPOUSE DROVE THE PATIENT TO THE CLOSEST HOSPITAL THEY THOUGH WOULD BE KNOWLEDGE ABOUT THE PUMP; THE HOSPITAL WAS NOT. THE SECOND TIME, AN AMBULANCE WAS CALLED. THE AMBULANCE HAD TO GO TO THE NEAREST HOSPITAL; SPOUSE STATES THE NEAREST HOSPITAL DID NOT KNOW ABOUT THE PUMP AND THEY WASTED 6 HOURS AS THEY TRIED TO FIGURE OUT WHAT TO DO. REPORTEDLY, THE PATIENT HAS SEIZURES AND WENT INTO A COMA. THE PATIENT WAS EVENTUALLY TRANSFERRED TO A HOSPITAL IN ANOTHER CITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N'VISION LKK MEDTRONIC NEUROMODULATION 8840 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Life Threatening| R CATHETER MODEL 8731 LOT# N002170413| EXPLANTED| IMPLANTED| IMPLANTED| CATHETER MODEL 8731 LOT# N002170413| EXPLANTED