BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3831825 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09603
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 7, 2014
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, 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.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED GEAR TRAIN ANOMALY, CORROSION AND OR WEAR AND OR LUBRICATION, STALL DUE TO SHAFT-BEARING. ANALYSIS OF THE CATHETER REVEALED NO SIGNIFICANT ANOMALY, MISCELLANEOUS ACCEPTABLE TESTING CATHETER INCOMPLETE/RETURNED IN SEGMENTS. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A MOTOR STALL WAS REPORTED. THE STALL RECOVERED AFTER MORE THAN 2 HOURS. DIAGNOSTIC/TROUBLESHOOTING INCLUDED A DYE STUDY. THE PATIENT EXPERIENCED UNDERDOSE SYMPTOMS, NAUSEA, VERY WEAK AND VOMITING. THE PUMP WAS REPLACED. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS INDICATED AS ALIVE, NO INJURY. THE PUMP WAS USED TO DELIVER MORPHINE. ADDITIONAL INFORMATION LATER REPORTED THAT THERE WAS NO EXPOSURE TO MRI OR EMI THAT THE REPORTER KNEW OF. THE PATIENT WAS INDICATED AS DOING ¿WELL¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311216 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention