BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2910361 · Received January 11, 2013

    Report

    Report Number
    3004209178-2013-00462
    Event Type
    Injury
    Date Received
    January 11, 2013
    Report Date
    December 18, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER, MODEL: 8709SC, SERIAL# (B)(4) IMPLANTED: (B)(6) 2011, EXPLANTED: 2012. (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 A MISCELLANEOUS ALARM ANOMALY WITH THE RESONATOR. THE PUMP PASSED ALL NONDESTRUCTIVE TESTING OTHER THAN THE ALARM TEST, WHICH FAILED WITH A READING OF 62.6 DB. THE ALARM PIN TEST WAS THEN DONE WITH A RESULT OF A PEAK TO PEAK VOLTAGE OF 6.84VDC AND A BATTERY VOLTAGE OF 2.92VDC, WHICH PASSED. THE RESONATOR WAS FOUND TO BE CRACKED. ANALYSIS OF THE CATHETER REVEALED A NON-SIGNIFICANT INDENT IN THE SC CONNECTOR SEAL WHICH DID NOT AFFECT INFUSION.

    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 THE PUMP AND CATHETER WERE EXPLANTED DUE TO INFECTION. PATIENT OUTCOME WAS NOTED AS RECOVERED WITHOUT SEQUELA. DRUG DELIVERED VIA THE DEVICE WAS MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17153 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention