BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3180691 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-10662
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    May 29, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PUMP WAS TO BE EXPLANTED BECAUSE THE THAT PATIENT DID NOT FEEL HE NEEDED IT ANYMORE. THE PATIENT WAS PROGRAMMED TO MINIMUM RATE. AT THE TIME OF THE REPORT, AN EXPLANT DATE HAD NOT BEEN SET. THERE WAS NO EXPLANATION FOR HOW THE CATHETER BECAME DISLODGED. THE PATIENT DID NOT HAVE ANY INJURIES OR DO ANY HEAVY ACTIVITY. THE PATIENT WAS REPORTEDLY DOING WELL. THERE WERE NO PUMP ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BEING SLOWLY TITRATED DOWN OVER TIME AND HAD REACHED A RATE OF 96MCG/DAY. AT THE TIME OF REPORT, THE PUMP WAS BEING REPROGRAMMED TO MINIMUM RATE MODE AND THE PATIENT WAS TO BE PUT ON ORAL BACLOFEN. IT WAS STATED THAT THE PATIENT WANTED TO GO OFF OF THE PUMP BECAUSE HE DIDN¿T WANT TO DEAL WITH IT. THERE HAD BEEN A PRIOR ISSUE WITH THE PATIENT¿S CATHETER A COUPLE OF MONTHS PRIOR TO REPORT. THE CATHETER HAD COME OUT OF THE SPINAL CANAL AND WAS CURLING AROUND THE ANTERIOR PORTION OF THE PUMP. ADDITIONALLY, WHEN THE REPLACEMENT WAS DONE, THE PHYSICIAN HAD PUNCTURED THE CATHETER BECAUSE IT WAS LYING OVER THE PORT. IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED WITHDRAWAL SYMPTOMS PRIOR TO THE REPLACEMENT SURGERY. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280590 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R