BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3243144 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12181
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    June 28, 2013
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED MOTOR GEAR TRAIN ANOMALY; CORROSION AND-OR WEAR AND-OR LUBRICATION. THE STALL WAS DUE TO SHAFT-BEARING.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8596SC SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8709SC LOT# N182665004, IMPLANTED: 2008 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8835 SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    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 LATER REPORTED THE MOTOR STALL OCCURRED ON (B)(6) AT 530 PM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS FRUSTRATED IN THAT HE WAS OFF OF WORK BECAUSE OF THE NEED FOR A PREMATURE PUMP REPLACEMENT. PATIENT WAS DISAPPOINTED REGARDING MOTOR STALL DUE TO CORROSION. PATIENT WAS GETTING GOOD RELIEF FROM NEW PUMP.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PERSONAL THERAPY MANAGER WAS READING A MOTOR STALL ON THE PUMP. A MOTOR STALL OCCURRED WITH NO RECOVERY. THE PUMP HAD BEEN STALLED FOR FOUR HOURS. THE PUMP WAS PLACED IN MINIMUM RATE. A PUMP REPLACEMENT WAS PLANNED. THE PUMP WAS DELIVERING HYDROMORPHONE AND BUPIVACAINE. IT WAS LATER REPORTED, THE PATIENT EXPERIENCED UNDERDOSE SYMPTOMS. THE PATIENT WAS MANAGED WITH ORAL MEDICATION THROUGH THE WEEKEND UNTIL SURGERY COULD BE SCHEDULED. THE PATIENT STATUS WAS ALIVE, NO INJURY. THE LOGS WERE CHECKED. THE PUMP WAS REPLACED. IT WAS LATER REPORTED, THE PATIENT EXPERIENCED WITHDRAWAL ON (B)(6) 2013. THE PATIENT PRESENTED TO THE EMERGENCY ROOM. A MOTOR STALL ALARM OCCURRED. THE PATIENT WAS GIVEN ORAL PAIN MEDICATION WITH SOME IMPROVEMENT OF SYMPTOMS. THE PUMP WAS INTERROGATED (B)(6) 2013 PRIOR TO REPLACEMENT AND THE PUMP WAS STILL STALLED AND HAD A TUBE SET LOG. IT WAS LATER REPORTED, THE PATIENT WAS STARTING TO FEEL AND EXPERIENCE MINOR SIGNS OF WITHDRAWAL. THE PUMP WAS PLACED IN MINIMUM RATE TO DECREASE ANY CHANCE OF OVERDOSE SINCE ORAL MEDICATION WAS BEING PRESCRIBED. IT WAS LATER REPORTED THE CAUSE OF THE MOTOR STALL WAS NOT DETERMINED. THE PATIENT IS MUCH IMPROVED AND RECEIVING THERAPEUTIC RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342374 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Other| R