BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2862627 · Received December 10, 2012

    Report

    Report Number
    3007566237-2012-02941
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 9, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE PREVIOUSLY REPORTED DEVICE MANUFACTURING INFORMATION HAS BEEN UPDATED PER THIS REPORT. THE PREVIOUSLY REPORTED EXPLANT DATE (B)(6) 2012 NO LONGER APPLIES. ADDITIONAL INFORMATION INDICATED THAT THE SYSTEM WAS NEVER EXPLANTED. PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS PUMP WAS BEING EXPLANTED. PRIOR TO THE EXPLANT, THE PATIENT HAD 275 MCG BACLOFEN REMAINING IN PUMP. THE REASON FOR EXPLANT WAS INDICATED AS "IT'S JUST NOT WORKING". THERE WERE NO SYMPTOMS REPORTED. THE DRUG DELIVERED VIA PUMP WAS BACLOFEN. ADDITIONAL INFORMATION HAD BEEN REPORTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FURTHER INFORMATION INITIALLY INDICATED THAT THE PATIENT'S DOSAGE HAD BEEN REDUCED TO MINIMUM INFUSION IN ORDER TO AVOID WITHDRAWAL. IT WAS REPORTED THAT THE PATIENT "NEVER BENEFITED FROM BACLOFEN THERAPY AND WANTED THE DEVICE REMOVED." ADDITIONAL INFORMATION INDICATED THAT NOTHING HAD BEEN EXPLANTED, AND THE PATIENT WAS RECEIVING 85MCG/DAY LIORESAL. THE PATIENT'S HEALTHCARE PROVIDERS WERE SWITCHING THE PATIENT'S MEDICATION TO DILAUDID AT HIS NEXT PUMP FILL ON (B)(6) 2013. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention