BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 9740125 · Received February 21, 2020

    Report

    Report Number
    3004209178-2020-03838
    Event Type
    Injury
    Date Received
    February 21, 2020
    Date of Event
    February 19, 2020
    Report Date
    May 26, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169530126
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3. ANALYSIS OF THE PUMP FOUND NO ANOMALIES. ANALYSIS OF THE CATHETER BODY FOUND DAMAGE TO THE TRANSITION TUBE. H6. THE RESULTS CODE 213 AND CONCLUSION CODE 67 REFERS TO THE PUMP. THE RESULTS CODE 180 AND THE CONCLUSION CODE 4315 REFERS TO THE CATHETER. 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

    CORRECTION: IT WAS ALSO REPORTED THE PATIENT WAS CONVINCED THE PATIENT WAS CAUSING SEIZURES ALTHOUGH THE PHYSICIAN FELT IT WAS NOT AND COULD NOT DIAGNOSE SEIZURE ETIOLOGY. THE PHYSICIAN WEANED DOWN THERAPY AND NORMAL SALINE WAS IN THE PUMP AT THE TIME OF EXPLANT. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. NO DIAGNOSTICS/TROUBLESHOOTING WERE PERFORMED. OTHER MEDICATIONS THE PATIENT WAS TAKING AT THE TIME OF THE EVENT INCLUDED: MICONOZIDE, COZAR, ALBUTEROL INHALER, FORTEO, LYRICA, FENTANYL, TESTOSTERONE, INSULIN, ASPIRIN, ALFUZOSIN, CLARITIN. THE PATIENT¿S MEDICAL HISTORY INCLUDED: BILATERAL CATARACTS, DIABETES TYPE 2, CHRONIC PAIN, PERIPHERAL NEUROPATHY, PEPTIC ULCER, OSTEOPOROSIS, CUSHINGS DISEASE, AND BENIGN PROSTATIC HYPERPLASIA.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2020. PRODUCT TYPE CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8780, SERIAL/LOT #: (B)(4), UBD: 18-NOV-2015, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PUMP AND CATHETER WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA AN MANUFACTURER'S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS RECEIVING SALINE VIA AN IMPLANTABLE INFUSION PUMP. IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING SEIZURES SINCE THE PUMP WAS IMPLANTED. THE PATIENT'S PUMP WAS WEANED DOWN AND THEIR PAIN WAS CONTROLLED BY ORAL OPIOIDS. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. A PART OF THE SPINAL SEGMENT WAS LEFT IN THE PATIENT TO PREVENT A SPINAL FLUID LEAK. THE PATIENT'S STATUS WAS NOTED AS "ALIVE-NO INJURY." NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201829 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169530126

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention