BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 13790161 · Received March 16, 2022

    Report

    Report Number
    3004209178-2022-03366
    Event Type
    Injury
    Date Received
    March 16, 2022
    Date of Event
    March 1, 2022
    Report Date
    May 31, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100824
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8596, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2022, PRODUCT TYPE: CATHETER. THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8596, SERIAL/LOT #: (B)(4), UBD: 15-SEP-2005, UDI#: (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE WAS SUBJECTED TO A SERIES OF STANDARD TESTS THAT INCLUDE BUT IS NOT LIMITED TO VISUAL INSPECTION, PATENCY TESTING, AND PRESSURE TESTING. ANALYSIS IDENTIFIED DAMAGE TO THE PUMP CONNECTOR WHICH IS CONSISTENT WITH EXPLANT DAMAGE. NO SIGNIFICANT ANOMALIES IDENTIFIED. 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 BACLOFEN (2000 MCG/ML AT 370 MCG/DAY) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE CATHETER WAS PARTIALLY EXPLANTED.  THE 8596 CONNECTOR WAS NOT FULLY INTACT AROUND THE COLLAR OF THE PUMP CONNECTOR; A TRIANGULAR SHAPED SECTION WAS MISSING. THE NEUROSURGEON MADE THE CLINICAL DECISION TO SPLICE ON A NEW PUMP CONNECTOR FROM A 8596SC KIT. THE PATIENT WAS NOT EXHIBITING ANY SIGNS OR SYMPTOMS. THE PUMP SEGMENT WAS REPLACED PROPHYLACTICALLY DUE TO PHYSICAL APPEARANCE OF EXISTING CONNECTOR. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT.  THE PATIENT WAS REPORTED ALIVE WITH NO INJURY. ON (B)(6) 2022 (B)(4) FOLLOW UP (REP) ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S MEDICAL HISTORY INCLUDED TRAUMATIC BRAIN INJURY, SEIZURE, DYSTONIA, SHUNT, TRACHEOSTOMY, ASTHMA, GASTROINTESTINAL TUBE. MEDICATIONS INCLUDED ULTRAM, HIPREX, PROVENTIL INHALER, ALBUTEROL INHALER. (B)(6) 2022 (B)(4) (REP) ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE CATHETER NOT BEING FULLY INTACT AROUND THE PUMP COLLAR WAS NEVER DETERMINED. THERE WERE NO EXTERNAL/ENVIRONMENTAL FACTORS THAT CONTRIBUTED TO THE EVENT. THE REPLACEMENT RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673477 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169100824

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Required Intervention "SEE H10...."