BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6704297 · Received July 11, 2017

    Report

    Report Number
    3004209178-2017-14633
    Event Type
    Injury
    Date Received
    July 11, 2017
    Date of Event
    July 5, 2017
    Report Date
    November 9, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169508156
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERS TO THE MAIN DEVICE, OTHER COMPONENTS INCLUDE: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: CATHETER. PRODUCT ID: 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: CATHETER. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE 8596SC CATHETER WAS RETURNED, AND ANALYSIS FOUND CORING-TEARS-CUTS IN THE CUP OF THE SC CONNECTOR (MEETING LEAK CRITERIA PER NDHF1162-113599). 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

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER'S REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING 2000 MCG/ML OF GABLOFEN AT 1000 MCG/DAY VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY. ON (B)(6) 2017, IT WAS REPORTED THAT THE PATIENT'S PUMP WAS REPLACED AS THE MANAGING HCP WAS HAVING DIFFICULTY ADJUSTING THE DAILY DOSE TO AN EFFECTIVE LEVEL. THE PATIENT WAS NOT RESPONDING TO MEDICATION ADJUSTMENTS AND WAS MORE SPASTIC THAN DESIRED. A SUCCESSFUL DYE STUDY HAD BEEN PERFORMED ON (B)(6) 2017 SHOWING NO APPARENT ISSUE TO THE CATHETER OR ROTORS. THE PATIENT'S PUMP HAD BEEN REPLACED, WITHOUT REPLACING THE CATHETER, IN (B)(6) 2017. IT WAS UNKNOWN IF ANY ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS HAD LED TO OR CONTRIBUTED TO THE ISSUE. AS THE PUMP HAD RECENTLY BEEN REPLACED AND DOSAGE ADJUSTMENTS WERE NOT EFFECTIVE, THE HCP DECIDED TO UPDATE THE PATIENT'S CATHETER ON (B)(6) 2017 AND RETURN THE OLD CATHETER. THE ISSUE WAS CONSIDERED RESOLVED. THE PATIENT'S STATUS WAS LISTED AS "ALIVE-NO INJURY". ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017 FROM THE MANUFACTURER'S REPRESENTATIVE. THE INITIAL REPORTER WAS IDENTIFIED AND THE TRACKING NUMBER FOR THE CATHETER THAT WAS BEING RETURNED WAS PROVIDED. NO FURTHER COMPLICATIONS WERE PROVIDED. THE PATIENT'S MEDICAL HISTORY INCLUDED CEREBRAL PALSY AND OTHER UNKNOWN ISSUES.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER. IT WAS REPORTED THE PATIENT HAD "FULL BODY EPISODES". TWO ELECTROENCEPHALOGRAMS (EEG) WERE DONE OVER THE SUMMER AND DETERMINED THESE WERE NOT SEIZURES. THE CATHETER WAS REPLACED BECAUSE OF THE FULL BODY EPISODES. THE PATIENT WAS HOSPITALIZED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481873 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169508156

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| R