BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 13049452 · Received December 20, 2021

    Report

    Report Number
    3004209178-2021-18820
    Event Type
    Injury
    Date Received
    December 20, 2021
    Report Date
    December 20, 2021
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780; SERIAL#: (B)(4); IMPLANTED: (B)(6) 2020; PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8780, SERIAL/LOT #: (B)(4), UBD: 11-OCT-2021, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780; SERIAL#: (B)(4); IMPLANTED: (B)(6) 2020; PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8780, SERIAL/LOT #: (B)(4), UBD: 11-OCT-2021, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, FRIEND/FAMILY MEMBER, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIVING LIORESAL (BACLOFEN) (2000 MCG/ML AT 1000 MCG/ DAY) VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY AND CEREBRAL PALSY. IT WAS REPORTED THAT THE PATIENT AND THE HEALTHCARE PROVIDER (HCP) CLAIMED THAT THE PATIENT WAS NOT EXPERIENCING EXPECTED THERAPY RESULTS FROM THE DEVICE. THE HCP  INCREASED THE DOSE OVER THE COURSE OF TIME AND THEN ATTEMPTED TO COMPLETE A CATHETER ACCESS PORT (CAP) STUDY. IT WAS MENTIONED THAT THE HCP WAS UNABLE TO ACCESS THE CATHETER ACCESS PORT AND HAD THE PATIENT FOLLOW UP WITH ANOTHER PHYSICIAN. THERE WAS NO ENVIRONMENTAL OR EXTERNAL FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. IT WAS REPORTED THAT A CAP STUDY WAS ATTEMPTED BUT COULD NOT BE COMPLETED. IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT SAW THE HCP FOR POSSIBLE CATHETER REVISION OR REPLACEMENT. IT WAS MENTIONED THAT DURING SURGERY, THE HCP CUT A SECTION OF THE CATHETER NEAR THE SPINE AND  CONFIRMED FLOW OF CEREBRA SPINAL FLUID (CSF). THE HCP ADDED A COLLET WHERE THEY MADE THE CUT AND THEN CHECKED THE PUMP POCKET FOR A K INKED CATHETER BUT DID NOT SEE ANYTHING OF CONCERN. THE HCP SUCCESSFULLY ASPIRATED THE FULL CATHETER FROM THE CAP PORT. THE HCP DECIDED TO REPLACE THE PUMP. THE PUMP WAS THEN REPLACED AND THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. AFTER PUMP REPLACEMENT, THE DOSE WAS DECREASED TO 100 MCG/DAY. PATIENT STATUS AT TIME OF REPORT WAS ALIVE -NO INJURY.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, FRIEND/FAMILY MEMBER, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIVING LIORESAL (BACLOFEN) (2000 MCG/ML AT 1000 MCG/ DAY) VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY AND CEREBRAL PALSY. IT WAS REPORTED THAT THE PATIENT AND THE HEALTHCARE PROVIDER (HCP) CLAIMED THAT THE PATIENT WAS NOT EXPERIENCING EXPECTED THERAPY RESULTS FROM THE DEVICE. THE HCP  INCREASED THE DOSE OVER THE COURSE OF TIME AND THEN ATTEMPTED TO COMPLETE A CATHETER ACCESS PORT (CAP) STUDY. IT WAS MENTIONED THAT THE HCP WAS UNABLE TO ACCESS THE CATHETER ACCESS PORT AND HAD THE PATIENT FOLLOW UP WITH ANOTHER PHYSICIAN. THERE WAS NO ENVIRONMENTAL OR EXTERNAL FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. IT WAS REPORTED THAT A CAP STUDY WAS ATTEMPTED BUT COULD NOT BE COMPLETED. IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT SAW THE HCP FOR POSSIBLE CATHETER REVISION OR REPLACEMENT. IT WAS MENTIONED THAT DURING SURGERY, THE HCP CUT A SECTION OF THE CATHETER NEAR THE SPINE AND  CONFIRMED FLOW OF CEREBRA SPINAL FLUID (CSF). THE HCP ADDED A COLLET WHERE THEY MADE THE CUT AND THEN CHECKED THE PUMP POCKET FOR A K INKED CATHETER BUT DID NOT SEE ANYTHING OF CONCERN. THE HCP SUCCESSFULLY ASPIRATED THE FULL CATHETER FROM THE CAP PORT. THE HCP DECIDED TO REPLACE THE PUMP. THE PUMP WAS THEN REPLACED AND THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. AFTER PUMP REPLACEMENT, THE DOSE WAS DECREASED TO 100 MCG/DAY. PATIENT STATUS AT TIME OF REPORT WAS ALIVE -NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947799 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169630505

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention