BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3232586 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11922
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 27, 2013
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE CATHETER FOUND THAT THE CATHETER WAS INCORRECTLY ASSEMBLED. EVEN THOUGH THE CATHETER HAD BEEN IMPLANTED FOR 24 MONTHS, THERE WERE NO INDENTS FROM THE SUTURES SEE ON THE ANCHOR AS WOULD BE EXPECTED. IT WAS FELT THAT WITHOUT SUTURES PLACED IN THE USUAL AREAS, THE ANCHOR WOULD NOT PROPERLY GRIP THE CATHETER AND COULD ALLOW THE CATHETER TO MIGRATE. IN ADDITION, THE AREA OF THE BREAK IN THE ANCHOR WAS UNUSUAL AND FOR THE CATHETER TO BREAK THE WAY THAT IT DID INDICATED IMPROPER SUTURING OF THE ANCHOR. THERE WAS ALSO A NARROWED AREA OF THE CATHETER SEEN ABOUT 19 TO 19.5CM FROM THE DISTAL TIP. THE NARROWED AREA APPEARED TO BE MORE FROM ABRASION ON BOTH SIDES OF THE CATHETER AS OPPOSED TO HAVING BEEN COMPRESSED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8596SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER HAD BACKED OUT OF THE INTRATHECAL SPACE AND THE ANCHOR HAD FRACTURED. THE PATIENT EXPERIENCED A RETURN OF SPASTICITY AND SPASMS IN HIS RIGHT LEG AND REQUIRED THE REPLACEMENT OF HIS SPINAL CATHETER SEGMENT. FOUR DAYS LATER, IT WAS REPORTED THAT THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334353 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention