BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4223258 · Received November 4, 2014

    Report

    Report Number
    3004209178-2014-20891
    Event Type
    Injury
    Date Received
    November 4, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE TIME OF THE PUMP REPLACEMENT (MFG. REPORT # 3004209178-2014-18135) THE PATIENT RECEIVED A LITTLE TOO MUCH BACLOFEN, SO THE HEALTHCARE PROVIDER (HCP) HAD TO REDUCE THE DOSAGE WITH THE REPLACEMENT PUMP. THE PUMP WAS USED TO DELIVER LIORESAL. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED. PLEASE REFER TO MFG. REPORT # 3004209178-2014-18137, AS THE PATIENT ALSO EXPERIENCED OVERDOSE SYMPTOMS AFTER THE PUMP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706147 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Other