BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4103254 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17426
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 27, 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
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SUB-OPTIMAL EFFECT. A DYE STUDY HAD BEEN PERFORMED. THE HEALTH CARE PROVIDER WAS UNABLE TO ASPIRATE THROUGH THE CATHETER ACCESS PORT, BUT HE PUSHED DYE THROUGH ANYWAY. THE PATIENT GOT A 220 UG BOLUS AND HAD OVERDOSE SYMPTOMS. THE PATIENT WAS MONITORED AND DID WELL FOLLOWING THE OVERDOSE. THE PATIENT HAD DECENT EFFECT FOR AWHILE AND THE ORAL MEDICATION WAS ABLE TO BE TAPERED OFF. IT WAS SUSPECTED THAT THE DYE STUDY HAD DISLODGED SOMETHING THAT WAS BLOCKING THE CATHETER. THE PATIENT DID WELL FOR ABOUT A MONTH FOLLOWING THE CATHETER STUDY, BUT NOW THE PATIENT WAS BACK TO NOT GETTING OPTIMAL EFFECT. THE LAST TWO REFILLS REVEALED UNDER-INFUSION. AN X-RAY OF THE CATHETER WAS INCONCLUSIVE. THE PUMP WAS PROGRAMMED TO DELIVER PERIODIC BOLUSES. A ROLLER STUDY WAS PERFORMED TO CONFIRM THE PUMP WAS FUNCTIONING. A CATHETER REPLACEMENT WAS PLANNED AND A PUMP REPLACEMENT WAS BEING CONSIDERED. IT WAS NOTED THAT THE LOGS WERE READ AND WERE NORMAL. THE PATIENT WAS SYMPTOMATIC A FEW MONTHS AGO, BUT THAT HAS SINCE RESOLVED. THE PATIENT EXPERIENCED AN INCREASE IN SPASTICITY, ITCHING, AND A RASH. ORAL BACLOFEN WAS ADDED AS A SUPPLEMENT TO TREAT THE PATIENT'S SPASTICITY. THE PATIENT WAS NOT CURRENTLY HAVING WITHDRAWAL SYMPTOMS, BUT WAS NOT HAVING THE BEST EFFECT HE HAD PREVIOUSLY. THE OUTCOME WAS ONGOING. THE DRUG IN THE PUMP WAS GABLOFEN. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THE PATIENT'S OUTCOME. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582580 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention