BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2963228 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02692
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003. PRODUCT TYPE: CATHETER: PRODUCT ID 8596, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INTRATHECAL GRANULOMA. AN X-RAY MAY BE ATTEMPTED TO VIEW THE CATHETER TIP. THE DRUG USED IN THIS SYSTEM WAS MORPHINE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT MAGNETIC RESONANCE IMAGING REVEALED CATHETER TIP GRANULOMA. THERE WAS SIGNIFICANT BIBASILAR ATELECTASIS. THE PATIENT WAS UNDER GENERAL ANESTHESIA DURING THE EXAM. THE PATIENT HAD A LEVOCURVATURE OF THE UPPER THORACIC SPINE AND A DEXTROCURVATURE OF THE THORACOLUMBAR JUNCTION. THE PATIENT HAD A SIGNIFICANT 7 MM LESION IDENTIFIED AT THE LEVEL OF T10 WITHIN THE SPINAL CANAL. IT WAS LOCATED POSTEROLATERALLY AND WAS IMPINGING UPON THE CORD CAUSING SEVERE CANAL STENOSIS. EXTENSIVE CORD EDEMA WAS SEEN FROM T9 THROUGH T12. THE CORD EDEMA DID NOT ENHANCE. THE LESION IN THE SPINAL CANAL DID ENHANCE WITH SOME RIM ENHANCEMENT AS WELL AS SOME INTERNAL ENHANCEMENT. THIS COULD REPRESENT A CATHETER TIP GRANULOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68930 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Other