BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2935260 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01113
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 13, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP (B)(4) REVEALED AN ALARM RESONATOR ANOMALY, A PUMP MOTOR GEAR TRAIN ANOMALY INVOLVING CORROSION AND/OR WEAR AND/OR LUBRICATION, AND A PUMP MOTOR GEAR TRAIN ANOMALY INVOLVING A STALL DUE TO THE SHAFT-BEARING. THE PUMP FAILED THE ALARM TEST WITH A READING OF 69.3 DB. MINIMAL SPECIFICATION IS 70.0 DB. THE ALARM WAVEFORM TEST WAS DONE AND IT YIELDED A PEAK TO PEAK VOLTAGE OF 6.88 V. THE BATTERY VOLTAGE DURING THE TEST WAS 2.84 VDC. THE PEAK TO PEAK VOLTAGE DURING THE TEST NEEDS TO BE A LEAST TWICE THAT OF THE PEAK TO PEAK VOLTAGE, WHICH IT IS. RESIDUE AND SHAFT WEAR WERE FOUND ON THE UPPER SHAFT OF GEAR ONE CAUSING THE MOTOR TO STALL.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), 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 LATER REPORTED THAT FOLLOWING EXPLANT THE PATIENT WAS "DOING FINE".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR STALL WITH NO RECOVERY OCCURRED. THE PATIENT EXPERIENCED PAIN, HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS NOT INJURED. THE PUMP WAS REPLACED. THE DEVICE SYSTEM WAS USED TO DELIVER SUFENTA AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40910 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention