BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 10268801 · Received July 13, 2020

    Report

    Report Number
    3004209178-2020-12100
    Event Type
    Injury
    Date Received
    July 13, 2020
    Date of Event
    July 5, 2020
    Report Date
    September 29, 2020
    Manufacturer
    MEDTRONIC 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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS SUBJECTED TO A SERIES OF STANDARD TESTS THAT INCLUDE BUT IS NOT LIMITED TO VISUAL INSPECTION, ALARM OUTPUT, MOTOR FUNCTION, AND DISPENSE TESTING. DESTRUCTIVE ANALYSIS IDENTIFIED RESIDUE IN THE MOTOR GEAR TRAIN AND WEARING ON THE UPPER SHAFT OF GEAR NUMBER TWO. MEDTRONIC DEVELOPED A DESIGN CHANGE TO REDUCE MOTOR SHAFT WEAR AND RECEIVED REGULATORY APPROVAL FOR THE CHANGE. MEDTRONIC BEGAN DISTRIBUTING PUMPS WITH THIS DESIGN CHANGE IN AUGUST 2017. 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

    INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING MORPHINE 350 MCG/ML FOR A TOTAL DOSE OF 399.46 MCG/DAY, ROPIVACAINE (NAROPIN) 9500 MCG/ML FOR A TOTAL DOSE OF 10842.4 MCG/DAY, AND PRIALT/ZICONOTIDE 2.1 MCG/ML FOR A TOTAL DOSE OF 2.3967 MCG/DAY VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT A MOTOR STALL OCCURRED. IT WAS NOTED THAT THE PUMP MOTOR DID NOT RESTART AND THE PATIENT WAS UNABLE TO RECEIVE THEIR TREATMENT; THUS, INCREASING THEIR PAIN. IT WAS NOTED ON (B)(6) 2020 THE PATIENT DID AN ELECTROMYOGRAM AROUND THE PERINEAL AREA DUE TO AN INCREASED IN THEIR PAIN FOR A FEW WEEKS. AN INTERROGATION OF THE PUMP JOURNAL REVEALED A MOTOR STALL OCCURRED ON (B)(6) 2020 AT 9:49PM WITH A MOTOR STALL RECOVERY ON (B)(6) 2020 AT 10:52PM, A MOTOR STALL OCCURRED ON (B)(6) 2020 AT 3:54AM WITH A MOTOR STALL RECOVERY ON (B)(6) 2020 AT 6:07AM, A MOTOR STALL OCCURRED ON (B)(6) 2020 AT 7:45AM WITH A MOTOR STALL RECOVERY ON (B)(6) 2020 AT 12:24PM, A MOTOR STALL OCCURRED ON (B)(6) 2020 AT 3:04PM WITH A MOTOR STALL RECOVERY ON (B)(6) 2020 AT 9:55PM, A MOTOR STALL OCCURRED ON (B)(6) 2020 AT 11:15PM WITH A MOTOR STALL RECOVERY ON (B)(6) 2020 AT 6:26PM, A MOTOR STALL OCCURRED ON (B)(6) 2020 AT 7:44PM WITH A MOTOR STALL RECOVERY ON (B)(6) 2020 AT 6:09PM, A MOTOR STALL OCCURRED ON (B)(6) 2020 AT 6:55PM WITH A MOTOR STALL RECOVERY ON (B)(6) 2020 AT 5:00PM, A MOTOR STALL OCCURRED ON (B)(6) 2020 AT 6:02PM WITH A MOTOR STALL RECOVERY ON (B)(6) 2020 AT 6:07PM, A MOTOR STALL OCCURRED ON (B)(6) 2020 AT 6:27PM WITH A MOTOR STALL RECOVERY ON (B)(6) 2020 AT 6:36PM, AND A MOTOR STALL OCCURRED ON (B)(6) 2020 AT 6:58PM WITH NO RECOVERY IN THE LOGS. THE LOGS INDICATED ON (B)(6) 2020 A LOW RESERVOIR ALARM OCCURRED. IT WAS NOTED SURGICAL INTERVENTION OCCURRED AS THE NEUROSURGEON DID AN EMERGENCY REPLACEMENT OF THE PUMP ON (B)(6) 2020 TO ENSURE THERE WAS NO WITHDRAWAL PHENOMENON. IT WAS NOTED THE PUMP WOULD BE RETURNED. IT WAS NOTED THAT THE ISSUE WAS RESOLVED AT TIME OF REPORT. THE PATIENT'S STATUS AT TIME OF REPORT WAS ALIVE, NO INJURY. THE PATIENT'S GENDER WAS PROVIDED. THE PATIENT'S WEIGHT, AGE, AND MEDICAL HISTORY WAS ASKED, BUT UNKNOWN. THE EVENT DATE WAS (B)(6) 2020. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726671 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention