BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4122926 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17834
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 3, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP SERIAL NUMBER (B)(4) FOUND PUMP MOTOR GEAR TRAIN ANOMALY, CORROSION AND-OR WEAR AND-OR LUBRICATION. ANALYSIS FOUND PUMP MOTOR GEAR TRAIN ANOMALY, STALL DUE TO SHAFT-BEARING.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8 590-1, LOT# N257985, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY; PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    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 THAT ON THE EVENT DATE, AT 8:05 PM, A 8476 PUMP MOTOR STALL ERROR CODE WAS NOTED ON THE PATIENT¿S PERSONAL THERAPY MANAGER (PTM). THE PATIENT WAS HAVING A LOT OF PAIN AND HADN¿T HAD THERAPEUTIC EFFECT SINCE HE GOT THE ERROR CODE. THE PAIN WAS RATED ON A SCALE FROM 0 TO 10 AS 13.7. THE PATIENT HAD NEVER FELT PAIN LIKE THIS IN HIS LIFE. HE HAD LEFT A MESSAGE WITH THE HEALTH CARE PROVIDER (HCP) OFFICE THE MORNING OF THE DATE OF THIS REPORT. LATER THE SAME DAY, A DEVICE MANUFACTURER REPRESENTATIVE WAS THEN WITH THE PATIENT IN THE CLINIC. THE PATIENT HAD REBOUND PAIN SINCE THE ERROR CODE AS PREVIOUSLY REPORTED. THERE HAD NOT BEEN AN MRI OR ANY EMI (ELECTROMAGNETIC INTERFERENCE) THAT WAS SUSPECTED AND THIS WAS LATER RE-CONFIRMED. THE REPRESENTATIVE WAS PLANNING ON SILENCING THE ALARMS. THE FOLLOWING DAY, THE MOTOR STALL WAS CONFIRMED TO HAVE OCCURRED ON THE EVENT DATE AT 8:25 VIA EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. IT WAS NOTED THE VERBIAGE PUMP RESTARTED DUE TO RESTART COMMAND WAS IN THE LOGS HOWEVER IT WAS CONFIRMED THERE WAS NO RECOVERY OF THE STALL. THE PATIENT WAS NOW IN THE ER (EMERGENCY ROOM) REPORTING AN INCREASE IN PAIN/RETURN OF SYMPTOMS THAT HAD STARTED 20 MINUTES FOLLOWING THE STALL AND HE FELT LIKE THE PUMP WAS NOT GIVING HIM MEDICATION. WHILE IN THE ER, HE WAS TREATED FOR WITHDRAWAL SYMPTOMS. IT WAS NOTED THE PATIENT¿S HCP HAD INSTRUCTED THE PATIENT TO COME IN FOR A REFILL BUT HAD THE DEVICE MANUFACTURER REPRESENTATIVE HAD STATED A REFILL WOULDN¿T FIX THE PROBLEM. WHILE IN THE ER, THE PATIENT WAS BEING GIVEN MEDICATIONS THROUGH IV HOWEVER THE REPRESENTATIVE WASN¿T SURE WHICH MEDICATIONS. IT WAS CONFIRMED THERE WAS ONLY ONE STALL THAT NEVER RECOVERED AND THE REASON FOR THE STALL REMAINED UNKNOWN. IT WAS THEN REPORTED THE PATIENT WAS SUPPOSED TO SEE THEIR HCP ON (B)(6) 2014 FOR A POTENTIAL PUMP REPLACEMENT. A PUMP REPLACEMENT DID THEN OCCUR. IT WAS ALSO LATER NOTED THE STALL DID NOT EVER RECOVER AND A TUBE SET MESSAGE THEN ALSO OCCURRED ON (B)(6) 2014. FOLLOWING THE REPLACEMENT, THE PATIENT RECOVERED WITHOUT SEQUELA. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE, FENTANYL, BUPIVACAINE, KETAMINE AND CLONIDINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HEALTH CARE PROVIDER (HCP) OR DEVICE MANUFACTURER REPRESENTATIVE AND THEY HAD AN APPOINTMENT DATE LISTED AS "SURGERY (B)(6) 2014". IT WAS ALSO NOTED AGAIN THE PATIENT WAS HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT THAT THEY HADN'T SOUGH FURTHER HELP AS WELL. IT WAS UNCLEAR IF THE INFORMATION RECEIVED HAD BEEN ANSWERED PRIOR TO THE PUMP REPLACEMENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600809 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention