BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1083474 · Received July 29, 2008

    Report

    Report Number
    2182207-2008-04490
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    June 28, 2008
    Report Date
    September 29, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. ALL PREVIOUSLY REPORTED PATIENT AND DEVICE CODES WILL BE UPDATED/CORRECTED TO THE FOLLOWING FOR THIS EVENT: (B)(4). EVAL CODE - CONCLUSION CODE ARE BEING UPDATED FOR THIS EVENT REGARDING THE PUMP. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED TO INCLUDE BOTH PRODUCT PROBLEM AND ADVERSE EVENT. EVAL CODE-CONCLUSION HAS BEEN UPDATED TO CODE-CONCLUSION FOR THE CATHETER (CODE-CONCLUSION REMAINS APPLICABLE FOR THE PUMP). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 8709, SERIAL# (B(4), IMPLANTED: (B)(6) 2000. ANALYSIS OF THE PUMP FOUND END OF SERVICE (EOS) DUE TO TIME PROGRESSION. ANALYSIS OF THE CATHETER/PUMP CONNECTOR/MODEL 8709 REVEALED LEAKS BETWEEN METAL PIN AND WHITE MATERIAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A "CHANGE IN THERAPY EFFECT". THE PATIENT'S MOTHER HAD RECENT VIRAL ILLNESS AND THE PATIENT PRESENTED WITH FEVER AND RESPIRATORY ISSUES. THE SYMPTOMS BEGAN IN 2008 AND THE PATIENT WAS ADMITTED TO THE HOSPITAL ON THREE DAYS LATER. THE HCP WAS QUESTIONING PNEUMONIA, SEPSIS, VIRAL INFECTION AND ALSO WANTED TO RULE OUT INTRATHECAL BACLOFEN WITHDRAWAL. THE DOSE WAS INCREASED BY 10% AND THE PATIENT WAS RECEIVING 850 MCG/DAY OF 2000 MCG/ML. THE PATIENT WAS PLACED ON A VENTILATOR AND ADMINISTERED PARALYTIC MEDICATIONS, SO IT WAS HARD TO TELL IF THE SPASMS WERE UNDER CONTROL WITH THE DOSE INCREASE. THE SYMPTOMS BEGAN DURING A NORMAL REFILL CYCLE. NO ALARMS HAVE BEEN NOTED. THE PUMP RESERVOIR HAS NOT BEEN CHECKED FOR VOLUME DISCREPANCIES; NO DIAGNOSTIC STUDIES HAVE BEEN PERFORMED. THE EVENT LOGS WERE ACCESSED AND WERE REPORTED TO BE "NORMAL". THE HCP BELIEVED THAT THIS EVENT MAY NOT BE PUMP RELATED; THE SYMPTOMS ARE SIMILAR TO ITB WITHDRAWAL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE (REP) VIA THE RETURN PAPERWORK FOR THE PUMP AND CATHETER. IT WAS NOTED THE REPORTER WAS NOT AWARE OF A COMPLAINT ASSOCIATED WITH ANY OF THESE PRODUCTS. FURTHER INFORMATION WAS NOT PROVIDED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED OR EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| L| R EXPLANTED:| CATHETER MODEL 8709 LOT# L81057| IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNKNOWN