BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3150553 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-08737
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 10, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE IMPLANT ON (B)(6) 2011, THE PATIENT WAS NOT GETTING RELIEF FROM THE PAIN IN THE AREA THAT SHE HAD THE PAIN (RIGHT SIDE THORACIC AREA). IT WAS INDICATED THAT SHE HAD THE PAIN FOR 10 YEARS. EVEN WITH THE CHANGING AMOUNT OF MEDICATION, THE PATIENT WAS NOT SEEING ANY PAIN RELIEF AT ALL. AN X-RAY OF THE CATHETER WAS DONE APPROXIMATELY TWO WEEKS AGO, AND IT SHOWED THAT THE CATHETER TIP HAD MIGRATED SLIGHTLY AND PER THE FAMILY, ¿NOT ENOUGH¿ FOR THE HCP TO BE CONCERNED ABOUT IT. THE REPORTER WAS NOT AWARE OF ANY RESERVOIR VOLUME DISCREPANCIES AT PUMP REFILLS. THE FAMILY MEMBER WAS QUESTIONING WHETHER OR NOT THE CATHETER TIP WAS PLACED HIGH ENOUGH IN THE INTRATHECAL SPACE. THE PUMP WAS USED TO DELIVER BUPIVACAINE AND BACLOFEN THE HCP LATER REPORTED THEY HAD NO KNOWLEDGE OF THE LACK OF THERAPEUTIC EFFECT, CATHETER MIGRATION, AND PAIN ON THE RIGHT SIDE OF THE PATIENT¿S BODY OCCURRING ON (B)(6) 2013. PER THE CLINICIAN NOTES, THE PATIENT WAS SEEN ON (B)(6) 201. THE PATIENT¿S PAIN HAD BECOME MORE CONSTANT, AND FOR THE PAST NINE YEARS, THE PAIN HAD INCREASED WITH SITTING. INCREASED ACTIVITY AND LYING DOWN APPEARED TO HELP THE PAIN. THE PATIENT ALSO EXPERIENCED HAVING SOME PAIN IN THE RIGHT CHEST WALL AREA. THE HCP NOTED THAT THE PATIENT¿S INTRATHECAL CATHETER TIP WAS AT ABOUT THE TOP OF T 11, T12 AND WAS QUITE SATISFACTORY. THE PHYSICIAN HAD A LONG DISCUSSION WITH THE PATIENT REGARDING THE CAUSE OF THE PATIENT¿S INCREASED PAIN WHILE SITTING. IT WAS THOUGHT THAT IT MIGHT BE NECESSARY TO INCREASE THE CONCENTRATION OF THE BACLOFEN IN THE PUMP WHICH MAY ALLOW FOR IMPROVED CONTROL OF THE PATIENT¿S PAIN. THE PATIENT WAS INSTRUCTED TO STOP TAKING ORAL BACLOFEN, AND THE PATIENT¿S NEXT REFILL DATE WAS SCHEDULED FOR (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250459 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1