BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 14079683 · Received April 11, 2022

    Report

    Report Number
    3004209178-2022-04561
    Event Type
    Injury
    Date Received
    April 11, 2022
    Date of Event
    March 25, 2022
    Report Date
    June 8, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100831
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: #(B)(4),TAYLOT19; (B)(6) 2022 EQUIPMENT LIST: ES028799- 1100 SOUND LEVEL METER ES049025- STOPWATCH ES044313- DISPENSE BATH ACCLIMATING ON (B)(6) 2022 @ 12:00 PM CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8637-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2022, PRODUCT TYPE: PUMP. PRODUCT ID: 8709, SERIAL# (B)(4), PRODUCT TYPE: CATHETER. THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8709, SERIAL/LOT #: (B)(4), UBD: 09-MAR-2011, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF CATHETER (S/N: (B)(6)) IDENTIFIED A BREAK IN THE CATHETER AND AN AREA WHERE THE CATHETER HAD BEEN ABRADED. THE ABRASION HAD BREACHED THE INNER LUMEN OF THE CATHETER AND A LEAK WAS DEVELOPED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIVING GABLOFEN (2,000 MCG/ML AND 505.1 MCG/DAY) VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY AND CEREBRAL PALSY. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) OPENED THE POCKET FOR THE NORMAL PUMP REPLACEMENT AND AS THEY ATTEMPTED TO ASPIRATE FROM THE ( CATHETER ACCESS PORT) CAP IT WAS NOT SUCCESSFUL. THEY CUT THE CONNECTOR AND ATTEMPTED TO PUT AN 25 GAUGE NEEDLE ONTO THE PUMP SEGMENT AND ASPIRATE AND STILL COULD NOT ASPIRATE. THE HCP LOCATED THE ANCHOR SITE THROUGH THE SPINAL INCISION, CUT BELOW IT BUT THE CATHETER SLID OUT OF THE SPINAL SEGMENT, BUT NOT ITS ENTIRETY. THEY MEASURED AND REALIZED 16.8 CM OF SPINAL CATHETER WAS STILL IN THE SPINE. X RAY CONFIRMED IT WAS AT T10. THE HCP THEN DECIDED TO ABANDON THAT CATHETER AND INSERT A NEW 8780 SPINAL SEGMENT AND GOT CEREBRA SPINAL FLUID (CSF) FLOW IMMEDIATELY AND WAS ABLE TO SUCCESSFULLY ASPIRATE FROM THE CAP ONCE THEY CONNECTED THE NEW SPINAL SEGMENT TO THE NEW POMP SEGMENT THEN TO THE NEW PUMP. TROUBLESHOOTING RESOLVED THE ISSUE. IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY RECENT DOSING TITRATIONS OR ANY PERIOD IN WHICH THEY WERE  IN WITHDRAWALS. THE MANAGING PHYSICIAN DECIDED TO DECREASED THEIR DOSE FROM 505.1 MCG PER DAY TO GO 100 MCGS PER DAY AT 2,000 MCG/ML OF BACLOFEN CONCENTRATION FOLLOWING TODAYS EVENTS. NO FACTORS HAVE LED TO THE ISSUE. PATIENT STATUS WAS ALIVE NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279340 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169100831

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male Required Intervention "SEE H10...."