BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3050870 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05881
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 11, 2013
    Report Date
    September 26, 2017
    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
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE PUMP REVEALED GEAR TRAIN ANOMALY; CORROSION AND-OR WEAR AND-OR LUBRICATION AND STALL DUE TO SHAFT BEARING. DURING ANALYSIS, SIGNIFICANT RESIDUE AND SHAFT WEAR ON THE UPPER SHAFT OF GEAR 2 WAS FOUND. SOME RESIDUE ON THE JEWEL WHERE THE UPPER SHAFT OF GEAR 2 INSERTS INTO THE TOP BRIDGE ASSEMBLY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE DEVICE SYSTEM; THE OTHER RELEVANT COMPONENTS INCLUDE: PRODUCT ID 8731SC, SERIAL# (B)(4) IMPLANTED: (B)(4) 2008 EXPLANTED: (B)(4) 2013. PRODUCT TYPE CATHETER. 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

    IT WAS REPORTED THERE WAS A CRITICAL ALARM DUE TO A MOTOR STALL. THE LOGS SHOWED A HARD STALL HAD OCCURRED ON (B)(6) 2013 AT 8:11 P.M. AND THE PATIENT WAS EXPERIENCING FEELINGS OF WITHDRAWAL. THE SYMPTOMS REPORTED WERE SHAKINESS AND NAUSEA. THE REPORTER STATED THAT THE PATIENT HAD GONE THROUGH WITHDRAWAL ONE TIME BEFORE, SO THE PATIENT WAS FAMILIAR WITH THE FEELING. IT WAS NOTED THAT THIS WAS THE FIRST TIME THIS HEALTHCARE PROVIDER (HCP) HAD SEEN THE PATIENT AS HE WAS JUST TAKING OVER CARE FOR THE PATIENT'S CARE. THE PATIENT DENIED THERE WAS ANY MAGNETIC RESONANCE IMAGING (MRI) OR ELECTROMAGNETIC INTERFERENCE (EMI) INVOLVED. THE HEALTH CARE PROVIDER (HCP) WAS PLANNING TO COVER THE PATIENT WITH ORAL MEDICATION AND GET THE PATIENT REFERRED FOR REPLACEMENT OF THE PUMP AS SOON AS POSSIBLE. THE MEDICATION BEING DELIVERED IN THE PUMP WAS DILAUDID AND BUPIVACAINE. IT WAS LATER REPORTED THAT THE CRITICAL ALARM WAS BEING HEARD FOR "A WHILE NOW." THE MOTOR STALL PREVIOUSLY REPORTED STILL HAD NOT RECOVERED AND IT WAS THOUGHT THE HCP HAD TURNED THE ALARM OFF, BUT THE PATIENT WAS STILL HEARING THE ALARM. THE PATIENT WANTED TO HAVE THE PUMP REPLACED IN A DIFFERENT STATE WHICH THEY ARE LOCATED IN FOR PART OF THE YEAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS REPLACED ON (B)(6) 2013. BEFORE REPLACEMENT THE PATIENT HAD SYMPTOMS OF INCREASED PAIN, NAUSEA, AND 'FORMICATION.'

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER ON 2017-SEP-11. IT WAS REPORTED THAT THE PUMP HAD JUST SHUT DOWN AND QUIT WORKING COMPLETELY. THE PUMP AND CATHETER WERE REPLACED. THE PUMP WAS RETURNED TO THE MANUFACTURER. THE CONSUMER ALSO REPORTED THAT THEY HAD WORKED WITH A MANUFACTURER'S REPRESENTATIVE AROUND THIS TIME. THE DATE OF THE EVENT WAS (B)(6) 2013. THE PATIENT'S PUMP MEDICATION AT THE TIME WAS REPORTED AS DILAUDID AND BUPIVACAINE AT UNKNOWN CONCENTRATIONS AND DOSAGES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS ALARMING IN (B)(6) 2013. THE PUMP HAD REACHED ITS END OF SERVICE OR ¿WAS DEAD.¿ IT WAS REPORTED THAT ¿THEY SCANNED THE PUMP AND DETERMINED IT NEEDED TO BE REPLACED.¿ THE DEVICE WAS TO BE SENT BACK TO THE MANUFACTURER FOR ANALYSIS. IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED WITHDRAWAL SYMPTOMS, ¿LIKE THE PATIENT HAD THE FLU.¿ IT WAS NOTED THAT THE PATIENT COULDN¿T DRIVE, IT WAS UNCLEAR IF THAT WAS RELATED TO THE DEVICE, A CHOICE, OR IF THAT WAS A HISTORICAL/MEDICAL PROBLEM. THE DEVICE SYSTEM WAS USED TO INFUSE DILAUDID AND BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148464 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention