BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 8027953 · Received November 1, 2018

    Report

    Report Number
    3004209178-2018-24427
    Event Type
    Injury
    Date Received
    November 1, 2018
    Date of Event
    October 31, 2018
    Report Date
    January 4, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100824
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF IMPLANTABLE PUMP SERIAL NUMBER (B)(4) REVEALED RESIDUE IN THE MOTOR GEAR TRAIN AND WEARING ON THE UPPER SHAFT OF GEAR NUMBER TWO. THE EVALUATION CODES HAVE BEEN UPDATED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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 · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. H6: THE EVALUATION CODES HAVE BEEN UPDATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE. THE REP STATED THEY WERE FIRST NOTIFIED OF THE STALL ON (B)(6) 2018, AS PREVIOUSLY INDICATED. THE PATIENT WAS ADVISED TO SEE THEIR MANAGING PHYSICIAN ON (B)(6) 2018, WHICH THEY DID. THE PATIENT'S DEVICE WAS INTERROGATED HOWEVER THE CAUSE OF THE STALL COULD NOT BE DIAGNOSED. THE PATIENT WAS REFERRED TO SEE AN IMPLANTING PHYSICIAN FOR A POSSIBLE REVISION AND REPLACEMENT. THE PATIENT'S WEIGHT WAS UNKNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE. THE PUMP STALLED MULTIPLE TIMES ON (B)(6); NOT RELATED TO MAGNETIC RESONANCE IMAGING. THE PATIENT FELT AN INCREASE IN PAIN (B)(6) AND AGAIN (B)(6). THE PATIENT WAS ADMITTED TO THE HOSPITAL (B)(6). THE PATIENT WAS PLACED ON 50 MCG FENTANYL SINCE THE STALL AND NORCO 5/325 EVERY SIX 6 HOURS PRN (AS NEEDED). THE PUMP WAS DELIVERING DILAUDID 12 MG/ ML MINIMUM RATE AND CLONIDINE 75 MCG/ML; MINIMUM RATE. IT WAS UNKNOWN IF ANY ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PUMP WAS EXPLANTED (B)(6) 2018 AND WILL BE RETURNED TO THE MANUFACTURER. THE ISSUE WAS RESOLVED. PATIENT STATUS WAS ALIVE - NO INJURY. MEDICAL HISTORY WAS ASKED AND WILL NOT BE MADE AVAILABLE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A DEVICE MANUFACTURER REPRESENTATIVE REGARDING A PATIENT RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE INFUSION PUMP. THE INDICATION FOR USE WAS SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT'S PERSONAL THERAPY MANAGER WAS DISPLAYING THE CODE 8476 (MOTOR STALL). NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE RETURNED LOGS INDICATED THE MOTOR STALLED ON (B)(6) 2018 AT 8:41 AM AND THE STALL RECOVERED AT 6:20 PM (THE SAME DAY). THE LOGS ALSO INDICATED A SUBSEQUENT MOTOR STALL OCCURRED ON (B)(6) 2018 AT 8:36 PM WITH A RECOVERY ON (B)(6) 2018 AT 10:20 AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870639 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169100824

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R