BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2864232 · Received December 10, 2012

    Report

    Report Number
    3007566237-2012-02960
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO WEEKS AFTER PUMP IMPLANT THE PATIENT DEVELOPED AN INFECTION IN THE PUMP POCKET. THE REPORTER STATED THAT THE PUMP POCKET WAS FILLED WITH PUS. THE PATIENT WAS CURRENTLY IN THE EMERGENCY ROOM (ER). THE REPORTER STATED THAT THE PATIENT WAS LARGE AND WAS DIABETIC AND HAD A LOT OF CO-MORBIDITIES. THE REPORTER STATED THAT THE PHYSICIAN WAS "OBVIOUSLY GOING TO TRY EXPLANT THE PUMP" AND MENTIONED POSSIBLY TYING OFF THE CATHETER AND LEAVING THE CATHETER IMPLANTED SINCE THERE WAS NO VISIBLE INFECTION IN THE SPINAL SITE AT THIS TIME. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THE PATIENT HAD MENINGITIS WITH SYMPTOMS OF FEVER, PAIN, INCISIONAL WOUND OPENING, AND MENINGEAL SIGNS AND SYMPTOMS. THE PATIENT'S ENTIRE SYSTEM WAS EXPLANTED, AND THEY WERE NOTED TO HAVE RECEIVED BOTH IV AND ORAL ANTIBIOTICS. THE INFECTION WAS NOTED TO HAVE RESOLVED. THE MEDICATION USED WITHIN THE SYSTEM WAS BACLOFEN. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention