BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3068925 · Received April 19, 2013

    Report

    Report Number
    3004209178-2013-06601
    Event Type
    Injury
    Date Received
    April 19, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8590-1, LOT# N160879, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. ALL PREVIOUSLY REPORTED PATIENT AND DEVICE CODES WILL BE UPDATED/CORRECTED TO THE FOLLOWING FOR THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    (CATHETER MIGRATION - PLEASE SEE MANUFACTURER REPORT # 3004209178-2013-04486).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT WAS IN THE HOSPITAL POST A CATHETER REVISION ON (B)(6) 2013. THE CATHETER WAS NOT IN THE CEREBRAL SPINAL FLUID BUT IN THE SUBCUTANEOUS TISSUE. AFTER THE REVISION, THE PATIENT EXPERIENCED LETHARGY, NAUSEA, TINGLING, AND VOMITING. THERE WAS CONCERN THAT THE PATIENT WAS 'KIND OF OVERDOSED.' IT WAS REQUESTED BY THE NEUROSURGEON TO STOP THE PUMP TO FURTHER TROUBLESHOOT. THE PATIENT'S DOSE WAS REPORTEDLY DECREASED BY 50% BEFORE THE REVISION. THIS DEVICE SYSTEM DELIVERED MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169836 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R