BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 13288548 · Received January 19, 2022

    Report

    Report Number
    3004209178-2022-00800
    Event Type
    Injury
    Date Received
    January 19, 2022
    Date of Event
    January 4, 2022
    Report Date
    July 12, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169630512
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    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: 8784, SERIAL#: (B)(4), EXPLANTED: (B)(6) 2022, PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8784, SERIAL/LOT #: (B)(4), UBD: 20-MAR-2022, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: 8784, SERIAL# (B)(6), EXPLANTED: (B)(6) 2022, PRODUCT TYPE: 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 8784 LOT# SERIAL# (B)(6) , IMPLANTED: EXPLANTED: (B)(6) 2022,PRODUCT TYPE CATHETER H3: THE CATHETER WAS RETURNED AND IT WAS IDENTIFIED THAT THERE WAS A BREAK IN THE CATHETER BODY, DAMAGE TO THE TRANSITION TUBING AND TWISTING IN 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

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS RECEIVING DILAUDID (HYDROMORPHONE) (180 MCG/ML AT 30 MCG/DAY) AND BUPIVACAINE (10 MG/ML AT 3.3 MG/DAY) VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT PATIENT STATED THEY HAS BEEN EXPERIENCING A HEADACHE OVER THE PAST 10 DAYS AND ON (B)(6) 2021 NOTICED HER PAIN LEVEL HAD INCREASED, EXPERIENCED SHAKING. THE PATIENT RECENTLY LOST 30 LBS AND PUMP LOOSE IN ABDOMEN. PATIENT ALSO HAS " TWIDDLES SYNDROME" AND THE HEALTHCARE PROVIDER (HCP)STATED AT PUMP REFILL VISIT ON (B)(6) 2021 THE PUMP HAD BEEN FLIPPED UPSIDE DOWN WHICH NECESSITATED HIM FLIPPING THE PUMP BACK OVER IN ORDER TO REFILL THE RESERVOIR. PATIENT WAS ISSUED AN ABDOMINAL BINDER AND (B)(6) 2021 BUT PUMP CONTINUED TO BE LOOSE. UPON OPENING PUMP PACKETS SITE, IT WAS NOTED THAT THE CATHETER WAS COMPLETELY SHEARED OFF JUST ABOVE THE SUTURELESS CONNECTOR. THE HCP SUCTIONED 350 ML OF CLEAR FLUID FROM THE PUMP POCKET SITE WHICH HAD DEVELOPED OVER THE PAST TWO DAYS. AFTER PUMP DISCONNECTED FROM EXISTING CATHETER AND PUT ON BACK TABLE, PRIMING BOLUS WAS PROGRAMMED TO VERIFY MEDICATION COMING OUT FROM THE EXIT PORT OF THE PUMP.  NEW 8784 PUMP SEGMENT SPLICED ONTO EXISTING CATHETER AND ONCE REATTACHED TO THE PUMP, ACCESSED CATHETER ACCESS PORT  (CAP) WITH 24 GAUGE NON-CORING NEEDLE WITH CEREBRA SPINAL FLUID (CSF) EASILY OBTAINED AND NO AIR BUBBLES SEEN. HCP THEN SUTURED DOWN THE PUMP USING THAT FOUR TITANIUM LOOPS PRIOR TO CLOSING THE PUMP PACKETS INCISION SITE. THE ISSUE WAS RESOLVED AT TIME OF THE EVENT. THE PATIENT STATUS AT TIME OF REPORT WAS ALIVE NO INJURY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA COMPANY REPRESENTATIVE (REP) WHO REPORTED THAT THE PATIENT DID NOT EXHIBIT ANY SIGNS OR SYMPTOMS.WHEN REFILLING THE PUMP IN OFFICE, IT WAS FOUND THAT THE PUMP FLIPED IN THE PATIENT PUMP POCKET. THE FACTORS THAT MAY HAVE LED OR CONTRUBUTED TO THE ISSUE INCLUDED THE PATIENT HAD RECENTLY LOST 30 POUNDS.THE HCP MANUALLY FLIP THE PUMP OVER SO RESERVOIR COULD BE ACCESSED.WHEN EXPOSED ALL FOUR SUTURES (UTILIZING TITANIUM PUMP ANCHORS) WERE NOT INTACT DESPITE HAVING SUTURED INTO MUSCLE. THE HCP CREATED A MUSCLE FLAP TO PARTIALLY COVER PUMP THIS TIME AND SECURED PUMP USING SUTURES ON FOUR TITANIUM LOOPS ON PUMP. AT THE TIME OF THE REPORT, THE ISSUE WAS RESOLVED. THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. THE PATIENT MEDICAL HISTORIES INCLUDED SPINAL STENOSIS, HYSTERECTOMY, HIP REPLACEMENT LEFT AND RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804567 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169630512

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention