BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 7215910 · Received January 24, 2018

    Report

    Report Number
    3004209178-2018-01297
    Event Type
    Injury
    Date Received
    January 24, 2018
    Report Date
    January 24, 2018
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WITH AN IMPLANTABLE DRUG INFUSION PUMP INDICATED FOR NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. THE PUMP CONTAINED CLONIDINE, AN UNKNOWN BRAND OF BACLOFEN, AND DILAUDID; ALL WITH UNKNOWN CONCENTRATIONS AND DOSES. IT WAS REPORTED THE PATIENT HAD 4 SURGERIES ON THEIR SPINAL CORD SINCE SHE HAD THE PUMP IMPLANTED. PER THE PATIENT, THE SURGERIES WERE RELATED TO THE PUMP BUT COULDN¿T TELL HOW IT WAS RELATED. PER THE PATIENT, THE HEALTHCARE PROVIDERS WERE ALWAYS FRUSTRATED AS THEY COULD NOT CONTROL THE PATIENT¿S PAIN AFTER THE SURGERIES. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60596 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention