BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3935954 · Received July 15, 2014

    Report

    Report Number
    3004209178-2014-13038
    Event Type
    Injury
    Date Received
    July 15, 2014
    Report Date
    March 29, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    REVIEW OF THIS MDR AND ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE ARACHNOIDITIS WAS DETERMINED IN (B)(6) 2010. MULTIPLE LOCULATED CYSTS WERE FOUND IN MRI AFTER THE PATIENT STARTED COMPLAINING THE SYMPTOM OF HEADACHE HAD RETURNED. THE PATIENT WAS HAVING DIFFICULTY WITH GAIT. NO CAUSE WAS DETERMINED BUT IT WAS NOT BELIEVED TO BE DEVICE OR THERAPY RELATED. THE CYSTS STARTED CERVICALLY AND WENT TO THE T9 LEVEL. THE CYST WRAPPED AROUND HER SPINE FROM FRONT TO BACK, STARTING THORACIC AND LATER MOVING LUMBAR. IT WAS NOTED IT MAY HAVE ALWAYS BEEN LUMBAR. WHEN THE PATIENT HAD IMAGING IT WAS ALWAYS OF HER BRAIN AND THE CERVICAL/THORACIC AREA AND NO ONE EVER DID A LUMBAR UNTIL THEY WERE GOING TO TRY TO REMOVE IT. THE CYST WAS REALLY LONG. IT WAS ALSO NOTED THE SPINAL CORD WAS TETHERED DUE TO DIFFUSED ARACHNOIDITIS. THE SURGERY DID HAPPEN (B)(6) 2011. DUE TO THE SPINAL CORD TETHERING AND THE PLACEMENT OF THE CYSTS, THE CYSTS COULD NOT BE REMOVED, BUT A PENCIL POINT SHUNT WAS PLACED IN THE LUMBAR AREA FOR DRAINAGE. THIS HELPED MINIMALLY. THERE WAS NEVER A TRUE RESOLUTION AS BOTH SHUNTS (SEE MANUFACTURER REPORT # 3004209178-2014-12941) WERE STILL IMPLANTED. THE SYMPTOMS DID RESOLVE, BUT NO CAUSE FOR THE CONDITION WAS EVER FOUND. THE DEVICE AND THERAPY WAS ABLE TO BE RULED OUT. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED, BUT THE THERAPY WAS NOTED AS INTRATHECAL BACLOFEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN DISCOVERED THE PATIENT HAD AN ARACHNOID CYST WRAPPED AROUND HER SPINE AND PERFORMED A SURGERY IN 2011. AT THE BASE OF THE PATIENT¿S SPINE WAS A PENCIL POINT DRAINAGE SHUNT FROM THIS. IT WAS UNKNOWN WHAT MEDICATION THIS DEVICE SYSTEM DELIVERED AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413303 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention