BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3922880 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12625
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    February 7, 2014
    Report Date
    July 7, 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 Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING ONGOING LOWER LIMB SPASTICITY. THE DEVICE SYSTEM WAS BEING USED TO DELIVER LIORESAL. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT AFTER SOME INITIAL DOSE CHANGES AFTER IMPLANT, IT BECAME APPARENT THAT THE DEVICE WASN¿T WORKING. FROM WHAT THIS PHYSICIAN UNDERSTOOD, THE NEUROSURGEON DID NOT CONFIRM THE PLACEMENT OF THE CATHETER; HE SAW THE RADIOPAQUE DOT AND THOUGHT IT WAS IN THE INTRATHECAL SPACE, BUT IT WASN¿T CLEAR WHETHER IT HAD ASCENDED IN THE SPINAL COLUMN. THE PUMP MANAGING PHYSICIAN DID X-RAYS THAT ¿PUT THE TIP OF THE CATHETER IN A DUBIOUS POSITION¿. HE COULD NOT TELL EXACTLY WHERE IT WAS. HE RETURNED THE PATIENT DO THE NEUROSURGEON WHO DID AN MRI THAT SHOWED THE CATHETER TIP WAS OUTSIDE THE INTRATHECAL SPACE SOMEWHERE IN THE SUBCUTANEOUS TISSUE. THE CATHETER WAS REPLACED ON (B)(6) 2014. THE PUMP MANAGING PHYSICIAN WAS PRESENT FOR THAT PROCEDURE. WHEN THE SITE WAS OPENED, HE COULD SEE THE CATHETER COILED UP SUBCUTANEOUSLY. THE TIP POSITION OF THE NEW CATHETER WAS CONFIRMED IN THE OPERATING ROOM PRIOR TO REMOVING THE GUIDE WIRE. THE PUMP MANAGING PHYSICIAN CHECKED THE CATHETER TIP PLACEMENT AFTER SURGERY AND IT WAS STILL AT T8 POST SURGERY. THE PATIENT WAS DOING WELL NOW AND WAS GETTING GOOD THERAPEUTIC BENEFIT FROM THE PUMP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE REPORTER HAD FOUND OUT THAT THE DEVICE MANUFACTURER HAD CHANGED THE MATERIAL THAT THE CATHETER WAS MADE OF AND THE REPORTER WANTED TO MAKE A COMPLAINT IN REGARDS TO THE MATERIAL. THE NEW MATERIAL WAS REPORTEDLY NOT VISIBLE TO X-RAYS AND THERE WAS NO WAY TO TELL THE PLACEMENT OF IT. IT WAS REPORTED THEY CHECKED FOR A BASELINE, SO THEY COULD MONITOR THE PLACEMENT OF THE CATHETER AND IT WAS NOT VISIBLE. THE REPORTER FOUND THAT ¿A LITTLE ODD¿ BECAUSE THERE WAS NO WAY TO CHECK IT OTHER THAN THROUGH AN MRI OR A BOLUS BUT THAT WASN¿T GOING TO TELL HER WHERE THE PLACEMENT WAS AND THE REPORTER HAD NO WAY TO TELL WHERE IT WAS PLACED. IT WAS REPORTED ¿THEY¿ DON¿T WANT TO DO ¿THAT MRI AND IT IS COSTLY AND NO ONE IS TAKING RESPONSIBILITY¿. THE PUMP WAS ADJUSTED AND THE DOSE WAS UPPED 19 PERCENT ON THE DAY PRIOR TO THE DATE OF THIS REPORT. IT WAS LATER NOTED THAT FROM WHAT THIS PHYSICIAN UNDERSTOOD, THE NEUROSURGEON DID NOT CONFIRM THE PLACEMENT OF THE CATHETER BECAUSE HE HAD DIFFICULTY VISUALIZING IT WHEN HE SAW THE RADIOPAQUE DOT AND THOUGHT IT WAS IN THE INTRATHECAL SPACE, BUT IT WASN¿T CLEAR WHETHER IT HAD ASCENDED IN THE SPINAL COLUMN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400210 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention