BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4173586 · Received October 15, 2014

    Report

    Report Number
    3004209178-2014-19706
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    June 23, 2014
    Report Date
    September 24, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, LOT# N184826003, IMPLANTED: 2009 (B)(6); PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND A PUMP/MOTOR/GEAR TRAIN ANOMALY AND CORROSION AND/OR WEAR AND/OR LUBRICATION. THE STALL WAS DUE TO GEAR WHEEL THREE.

    Description of Event or Problem · 1

    IT WAS REPORTED A MOTOR STALL WAS NOTED IN THE EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. PUMP REPLACEMENT SURGERY WAS ORIGINALLY SCHEDULED FOR 2 WEEKS AGO, BUT WAS DELAYED BECAUSE OF A FAMILY EMERGENCY. THE PUMP WAS BEING REPLACED ON THE DATE OF THE REPORT. THE SURGERY WAS INITIALLY THOUGHT TO BE FOR NORMAL BATTERY REPLACEMENT, HOWEVER WHEN THE PUMP WAS INTERROGATED BEFORE SURGERY A ¿MOTOR STALL OCCURRED¿ MESSAGE WAS SEEN. THE MOTOR STALL HAD OCCURRED ON 2014 (B)(6). UPON FURTHER REVIEW, A PUMP UPDATE (REFILL) WAS DONE THREE DAYS AFTER THE STALL. AT THE REFILL, ALL THE MEDICATION WAS GOTTEN BACK. IT WAS LATER REPORTED, THE STALL WAS SEEN ON 2014 (B)(6) WHEN THE PATIENT WENT IN FOR A REFILL. THE PATIENT HAD BEEN RECEIVING ORAL DILAUDID AFTER THE STALL WAS NOTED AT THE REFILL. THE STALL WAS NOT THOUGHT TO BE RELATED TO MAGNETIC INTERFERENCE AND THE CAUSE OF THE STALL WAS NOT DETERMINED. THE PATIENT DID NOT MENTION HEARING AN ALARM. THERE WAS A WHILE WHEN THE PATIENT WAS ¿MISERABLE WITH PAIN.¿ THE NEW PUMP WAS PROGRAMMED AT THE LOWEST PROGRAMMABLE DOSE AND AN X-RAY SHOWED GOOD CATHETER POSITIONING. NO ROTOR STUDY OR DYE STUDY WAS PERFORMED. THE PATIENT RECOVERED WITHOUT SEQUELAE AND THERE WAS NO PATIENT INJURY. THE SYSTEM WAS BEING USED TO DELIVER DILAUDID, CLONIDINE, AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653765 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention