BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 7642404 · Received June 27, 2018

    Report

    Report Number
    3004209178-2018-14466
    Event Type
    Injury
    Date Received
    June 27, 2018
    Report Date
    October 4, 2018
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE CODES C62809, C63144, AND C62955 NO LONGER APPLY. EVAL CODE-CONCLUSION 92 NO LONGER APPLIES. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL. IT WAS REPORTED THAT THE CAUSE OF THE PUMP FLIPPING WAS NOT DETERMINED. THE PUMP FLIPPING, CATHETER TWISTING AND CATHETER NOT BEING IN THE INTRATHECAL SPACE WAS RESOLVED WITH REMOVAL OF THE AFFECTED DEVICES. THE PATIENT WAS MORBIDLY OBESE AT THE TIME OF THE EVENT. DEVICE RETURN WAS REQUESTED AND THE CURRENT STATUS WAS NOT REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    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) 2017, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8780, SERIAL/LOT #: (B)(4), UBD: 20-JAN-2019, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS RECEIVING MORPHINE (UNKNOWN CONCENTRATION AND DOSAGE) VIA AN IMPLANTABLE INFUSION PUMP FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT'S PUMP WAS REMOVED BECAUSE THE PUMP WAS NOT STABLE AND KEPT FLIPPING CAUSING DIFFICULTY DURING REFILLS. THE HEALTHCARE PROVIDER (HCP) WANTED TO ANCHOR IT. DURING THE REMOVAL SURGERY, IT WAS DETERMINED THAT THE CATHETER WAS NOT IN THE INTRATHECAL SPACE, LIKELY SINCE IMPLANT. THEREFORE, THE MORPHINE WAS NOT GOING WHERE IT SHOULD HAVE GONE. DURING THE REMOVAL SURGERY, IT WAS ALSO DISCOVERED THAT BECAUSE THE PUMP KEPT FLIPPING, THE HCP SAW THAT THE CATHETER WAS "WRAPPED AROUND THAT, AND THE INTESTINES." THE HCP DECIDED TO REMOVE THE PUMP AND CATHETER SO THE MORPHINE WAS NOT BEING DELIVERED TO SUBCUTANEOUS TISSUE. THE PATIENT'S PUMP WAS REMOVED ON "A THURSDAY", AND THE SURGEON WAS GOING TO PLACE THE NEW PUMP THE FOLLOWING TUESDAY. THE PATIENT DECIDED OVER THE WEEKEND BETWEEN THAT HE WANTED ANOTHER HCP TO DO THE IMPLANTING PROCEDURE. THE MORPHINE NURSE AND CAREGIVER SAID THE PUMP BEGAN FLIPPING AT IMPLANT, BUT THE PATIENT STATED IT BEGAN AFTER IMPLANT. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483140 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169530126

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention