BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4120850 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17777
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 28, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPDATE MADE; PREVIOUSLY REPORTED CODES NO LONGER APPLY.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND A GEAR TRAIN ANOMALY; CORROSION AND MOISTURE ON THE TOP SIDE OF GEAR WHEEL THREE. THE MOTOR STALL WAS DUE TO THE SHAFT BEARING.

    Additional Manufacturer Narrative · 1

    CONCLUSION: CODE IS NO LONGER APPLICABLE FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT MULTIPLE MOTOR STALLS HAD OCCURRED OVER SEVERAL DAYS LEADING TO ONE THAT DID NOT RECOVER. THE CAUSE OF THE STALLS WAS UNKNOWN. AS OF THE DATE OF REPORT, THE PATIENT HAD REPORTEDLY RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    THE PUMP MOTOR HAD STALLED A ¿FEW DAYS AGO¿ AND THE PUMP FAILED TO UPDATE PROPERLY. IT WAS UNKNOWN IF ANY DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED. ACCORDING TO THE PUMP LOGS, A MOTOR STALL HAD OCCURRED ON (B)(6) 2014 WITH NO RECOVERY RECORDED. AN EMERGENCY REPLACEMENT WAS PERFORMED. THE PATIENT EXPERIENCED INCREASED PAIN. THE PATIENT STATUS WAS 'ALIVE - NO INJURY'. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID AND CLONIDINE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601434 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention