BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 8003065 · Received October 24, 2018

    Report

    Report Number
    3004209178-2018-23850
    Event Type
    Malfunction
    Date Received
    October 24, 2018
    Date of Event
    September 26, 2018
    Report Date
    January 11, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169630505
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A CLINICAL STUDY INDICATED THE PATIENT'S BASELINE WEIGHT WAS NOT MEASURED. THE CAUSE OF THE CATHETER DISLODGEMENT WAS NOT DETERMINED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8709SC, SERIAL/LOT #: (B)(4), UBD: 02-AUG-2014, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONTINUATION: PRODUCT ID 8709SC LOT# SERIAL# (B)(4) IMPLANTED: 2012-(B)(6) EXPLANTED: PRODUCT TYPE CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE CATHETER. 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 PROFESSIONAL (HCP) VIA A CLINICAL STUDY REGARDING A PATIENT RECEIVING UNKNOWN BACLOFEN WITH AN UNKNOWN DOSE AND CONCENTRATION VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY AND MULTIPLE SCLEROSIS. IT WAS REPORTED ON (B)(6) 2018 THE PATIENT REPORTED WORSENING PAIN (DESCRIBED AS NEEDLES AND STABBING) AND UNCONTROLLED PAIN/LOSS OF THERAPEUTIC RELIEF. ON (B)(6) 2018 THE PATIENT WAS INSTRUCTED TO TAKE ORAL BACLOFEN AS NEEDED UNTIL THE PATIENT COULD COME TO THE OFFICE. ON (B)(6) 2018 THE PUMP WAS REPROGRAMMED WHERE THE INTRATHECAL (IT) RATE WAS INCREASED. ON (B)(6) 2018 THE PUMP WAS REPROGRAMMED WHERE THE IT RATE WAS INCREASED. ON (B)(6) 2018 A CATHETER ACCESS PORT (CAP) STUDY REVEALED THE CATHETER WAS DISLODGED. THE OUTCOME OF THE EVENT WAS NOTED AS ONGOING. THE DEVICE DIAGNOSIS WAS CATHETER DISLODGEMENT AND THE CLINICAL DIAGNOSIS WAS LOSS OF THERAPEUTIC EFFECT. THE ETIOLOGY OF THE EVENT INDICATED THE RELATIONSHIP OF THE EVENT TO THE DEVICE OR THERAPY WAS RELATED AND INDICATED THE RELATIONSHIP OF THE EVENT TO THE IMPLANT PROCEDURE WAS RELATED. THE SPECIFIC PORTION WAS THE INTRATHECAL/SPINAL PORTION. THE EVENT DATE WAS (B)(6) 2018. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER VIA A CLINICAL STUDY REPORTED THE CATHETER WAS SPLICED/REVISED ON 2018-(B)(6) AND NEW SPINAL SEGMENT WAS ADDED. THE ISSUE RESOLVED WITHOUT SEQUELAE ON 2018-(B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER VIA A CLINICAL STUDY REPORTED THE PATIENT WAS RECEIVING BACLOFEN (1000 MCG AT 99.92952 MCG/DAY) VIA AN IMPLANTABLE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840024 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169630505

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention