BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3930246 · Received July 11, 2014

    Report

    Report Number
    3004209178-2014-12933
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER; PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A RETURN OF SYMPTOMS. IT WAS NOTED THEY HAD AN INCREASE IN SPASTICITY WHICH STARTED THE DAY PRIOR AND GOT WORSE THE NEXT DAY. IT WAS REPORTED THE PATIENT ALSO FELT ITCHING AND TINGLING SENSATIONS. IT WAS NOTED THE PATIENT WAS RECEIVING ORAL BACLOFEN CURRENTLY. THE PUMP WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION REPORTED THERE WAS A CATHETER ISSUE. IT WAS STATED A DYE STUDY WAS PERFORMED ON (B)(6) 2014 BUT THEY WERE UNABLE TO ASPIRATE, SO THE PATIENT HAD A CATHETER REVISION THAT AFTERNOON. IT WAS STATED THE CATHETER SHEARED OFF AT THE SPINAL SEGMENT NEAR THE SUPRASPINOUS LIGAMENT AND THE DISTAL CATHETER WAS REPLACED. IT WAS STATED THE PUMP WAS ALSO ELECTIVELY REPLACED. IT WAS NOTED THE DOSE WAS REDUCED POST OP FROM 424 MCG TO 300MCG AND THE PATIENT WAS DOING WELL. IT WAS STATED THE PATIENT WAS EXPERIENCING ¿CLASSIC WITHDRAWAL SYMPTOMS¿ PRIOR TO THE DYE STUDY. THE PUMP WAS USED TO DELIVER GABLOFEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAS HAD SEVERAL REPLACEMENTS/REVISIONS AND THE SEGMENTS HAD BEEN PIECED TOGETHER OVER TIME. IT WAS NOTED THAT PART OF THE SPINAL SEGMENT WAS LEFT IN THE INTRATHECAL SPACE, AS IT WAS DIFFICULT TO REMOVE. IT WAS FURTHER REPORTED ONCE THE HEALTHCARE PROVIDER (HCP) WAS UNABLE TO ASPIRATE THEY SCHEDULED THE SURGERY BECAUSE THEY DID NOT WANT TO PUSH ADDITIONAL DRUG ON THE PATIENT WITH A FLUSH. IT WAS ALSO REPORTED THE PATIENT WAS DOING FINE NOW AFTER REVISION OF THE CATHETER AND REPLACEMENT OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406462 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR