BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 7744723 · Received August 2, 2018

    Report

    Report Number
    3004209178-2018-17309
    Event Type
    Injury
    Date Received
    August 2, 2018
    Date of Event
    July 13, 2018
    Report Date
    November 29, 2018
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT CODES HAVE BEEN UPDATED TO INCLUDE C50789. 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

    ON 2018-AUG-03, INFORMATION FROM (B)(6) 2018 WAS RECEIVED. IT WAS DETERMINED THE HCP STATED, "WE ARE REMOVING THE PUMP, HIS ERI WAS 10 MONTHS AND IT'S NEVER BEEN EFFECTIVE".

    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

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

    Description of Event or Problem · 1

    ON (B)(6) 2018, INFORMATION WAS RECEIVED FROM AN HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT RECEIVING DILAUDID (10 MG/ML, 1.4 MG/DAY) VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. THE PATIENT BEGAN EXPERIENCING WITHDRAWAL SYMPTOMS ON (B)(6) 2018 AND WENT TO THE ER FOR WITHDRAWAL ON (B)(6) 2018. ON (B)(6) 2018, THE HCP REPORTED MOTOR STALLS WERE SEEN AT INITIAL INTERROGATION. A MOTOR STALL OCCURRED ON (B)(6) 2018 FOR 7 MINUTES THEN RECOVERED. ANOTHER MOTOR STALL OCCURRED ON (B)(6) 2018 AND NEVER RECOVERED. THE HCP CONFIRMED THERE WERE NO ELECTROMAGNETIC INTERFERENCE (EMI) OR MAGNETIC SOURCES PRESENT. THE HCP PROGRAMMED THE PUMP TO MINIMUM RATE, SILENCED THE ALARM AND CHANGED THE ALARM INTERVAL. THE PUMP WAS ALARMING AGAIN, AND THE HCP BELIEVED A MOTOR STALL HAS OCCURRED AGAIN. THE HCP REPORTED THAT THE PUMP HAD 10 MONTHS UNTIL EARLY REPLACEMENT INDICATOR (ERI) SO THEY PLANNED TO EXPLANT THE PUMP. THE PATIENT'S WITHDRAWAL WAS ALREADY TAKEN CARE OF WITH ORAL MEDICATIONS BY THE HCP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. IT WAS REPORTED THAT THE PATIENT DID NOT HEAR THE BEEP OF THE PAIN PUMP CLEARLY. THERE WERE NO FURTHER COMPLICATIONS REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586540 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention