BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4241357 · Received November 10, 2014

    Report

    Report Number
    3004209178-2014-21255
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 18, 2007
    Report Date
    October 20, 2014
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER RECEIVED REPORTED SEVERE SPASTICITY NOT REALLY RESPONDING TO THE PUMP, OTHER FACTORS AS WELL SUCH AS DIFFICULTY GETTING INTO CLINIC FOR PUMP DOSE CHANGES.

    Description of Event or Problem · 1

    SINCE IMPLANT, THE PATIENT HAD NEVER RECEIVED THERAPEUTIC BENEFIT. THE DOCTOR THOUGHT IT WAS DUE TO THE PATIENT BEING IN A NURSING HOME, THE PATIENT¿S FAMILY CIRCUMSTANCES AND POTENTIALLY THE PUMP. THE PHYSICIAN FELT THAT SHE WAS NEVER ABLE TO GET THE PATIENT TO REACH EFFICACY BECAUSE OF ALL THE CIRCUMSTANCES AND THE PATIENT HAD BEEN HOSPITALIZED OFF AND ON FOR UNRELATED MEDICAL REASONS. THE DEVICE SYSTEM WAS DELIVERING GABLOFEN. THE OUTCOME WAS NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723198 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR