BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2864151 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11386
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 10, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# L70455, IMPLANTED: (B)(6) 2000. PRODUCT TYPE: CATHETER: PRODUCT ID 8703W, LOT# L59327, IMPLANTED: (B)(6) 2000. 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

    FINAL ANALYSIS OF THE PUMP FOUND NO ANOMALIES. .

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT HAD AN INFECTION PREVIOUSLY THAT HAD TRACKED TO THE PUMP POCKET. THE HCP WAS WORKING TO TITRATE THE PUMP DOSE DOWN SO THAT EXPLANT COULD OCCUR ON (B)(6) 2012. THE PATIENT EXPERIENCED INCREASED SPASTICITY AND UNDERDOSE SX. IT WAS LATER REPORTED THAT THE PUMP WAS EXPLANTED. THE PATIENT STATUS WAS REPORTED TO BE THE 'SAME'. THE PUMP WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention