BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2854657 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11064
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER 8711, LOT # J11479R61, IMPLANTED: (B)(6) 2003, EXPLANTED: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN UNABLE TO GET HIS SEIZURES UNDER CONTROL. THE PATIENT HAD A HISTORY OF SEIZURES AND PER THE REPORTER HAVE BEEN GETTING WORSE. IT WAS INDICATED THAT THE SEIZURES STARTED IN 2003 WHEN THE FIRST PUMP WAS IMPLANTED (AS PREVIOUSLY REPORTED IN MANUFACTURER REPORT # 6000030-2012-00213), HOWEVER, THE PATIENT'S MOTHER DID NOT BELIEVE THAT THE SEIZURES WERE RELATED TO THE IMPLANTATION OF THE PUMP SYSTEM, BECAUSE, DESPITE A DECREASE IN THE PATIENT'S BACLOFEN DOSE, THE SEIZURES CONTINUED TO OCCUR. THE PATIENT'S MOTHER ALSO REPORTED THAT HER SON'S SEIZURE ACTIVITY HAD CHANGED; THE SEIZURES BEGAN AS "SIMPLE" SEIZURES, THEN THEY PROGRESSED TO COMPLEX SEIZURES, AND RECENTLY THE SEIZURES PROGRESSED TO GRAND MAL SEIZURES. MOREOVER, THE PATIENT'S MOTHER ALSO REPORTED THAT HER SON EXPERIENCED "ENDOCRINE ISSUES,"; ENDOCRINE LABORATORY TESTS PRODUCED "SKEWED" RESULTS AFTER A YEAR AND "HIS CORTISOL [WAS] WAY TOO HIGH." THE PATIENT WAS SCHEDULED TO SEE A HEALTHCARE PROVIDER (HCP) IN NEUROLOGY ON (B)(6) 2012. THE PATIENT WAS ALSO SCHEDULED TO MEET WITH ANOTHER HCP IN (B)(6) 2013 TO DISCUSS PUMP REPLACEMENT. THE PUMP DELIVERED BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE TO US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Other