BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3150573 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-08739
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL PUMP ANALYSIS REVEALED MOTOR FEEDTHRU ANOMALY - SHORTING ACROSS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, 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 THE PATIENT¿S PUMP WAS READ ON (B)(6) 2013 AND THE ELECTIVE REPLACEMENT INDICATOR (ERI) ON THE PUMP SAID 30 MONTHS. WHEN THE PATIENT CAME BACK FOR A REFILL ON (B)(6) 2013 THE PUMP THEN SAID THAT ERI HAD OCCURRED AND THE SCHEDULED TO BE REPLACED BY DATE WAS (B)(6) 2013. ONCE THE ERI HAD OCCURRED, THE PUMP HAD STARTED BEEPING. IT WAS REPORTED NO FLOW RATE CHANGE HAD OCCURRED BETWEEN THE TWO TIMES. THE PATIENT HAD A PERSONAL THERAPY MANAGER (PTM) WHICH ALLOWED TWO ACTIVATIONS PER DAY. THE PATIENT WAS TO COME INTO THE HEALTH CARE PROVIDER¿S (HCP) OFFICE ON (B)(6) 2013. IT WAS NOTED THE HCP HAD BEEN TALKING ABOUT POSSIBLY REPLACING IT THE FOLLOWING MONDAY. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. IT WAS LATER REPORTED THE HCP DECIDED TO DO A PUMP REPLACEMENT ON (B)(6) 2013. IT WAS LATER REPORTED THE PATIENT DID EXPERIENCE WITHDRAWALS FOR WHICH HE HAD TO BE ADMITTED INTO THE HOSPITAL TO MANAGE HIS PAIN. NO OTHER SIGNIFICANT SIDE EFFECTS OCCURRED. THE PUMP REPLACEMENT WAS A SUCCESS. IT WAS REPORTED THE PUMP WAS ¿CERTAINLY MALFUNCTIONING¿ BY READING THE LOGS. IT WAS LATER REPORTED THE PUMP WAS REPLACED DUE ¿ERRATIC RESTARTING¿. PER THE PUMP LOGS AT WERE EXAMINED ON (B)(6) 2013, THE PUMP WAS IN SAFE STATE AND THE ESTIMATED ERI INDICATED 39 MONTHS. MULTIPLE ¿RESET OCCURRED- LOW BATTERY¿ AND ¿RESET OCCURRED¿ MESSAGES OCCURRED BETWEEN (B)(6) 2013 AND (B)(6) 2013. PER PUMP LOGS EXAMINED ON (B)(6) 2013, THE ERI AT THAT TIME HAD BEEN 30 MONTHS. THEN PUMP LOGS FROM (B)(6) 2013 INDICATED ERI HAD OCCURRED AND THE SCHEDULE TO REPLACE BY DATE WAS (B)(6) 2013. PUMP LOGS FROM (B)(6) 2013 AGAIN SHOWED ERI HAD OCCURRED AND THE SCHEDULE TO REPLACE BY DATE WAS (B)(6) 2013. IT WAS REPORTED THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251371 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R