BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2991086 · Received March 6, 2013

    Report

    Report Number
    3007566237-2013-00691
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE EXPECTED RESERVOIR VOLUME WAS 8.7 MILLILITERS (ML), HOWEVER, THE ACTUAL VOLUME WAS 11.0 ML.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SYMPTOMS OF UNDERDOSE THAT INCLUDED INCREASED SPASM AND TREMOR. THE SYMPTOM'S RESULTED IN IN-PATIENT HOSPITALIZATION. THE HEALTH CARE PROVIDER (HCP) ALSO REPORTED POSSIBLE CATHETER DISLODGEMENT. THE PUMP WAS INTERROGATED AND THE RETURNED RESULTS SHOWED THE PUMP FUNCTIONED NORMALLY WITH FOUR MONTHS UNTIL ITS END OF LIFE DATE ON (B)(4) 2013. ON (B)(6) 2013 THE HCP REPORTED THAT HE ADJUSTED THE PATIENT'S LIORESAL DOSE BY ADMINISTERING A "SURGE IN BACLOFEN" AND AN INCREASE IN DOSE OF EITHER INTRATHECAL OR ORAL BACLOFEN. ON THE SAME DAY, THE PATIENT UNDERWENT AN X-RAY TO VISUALIZE THE CATHETER, WHICH SHOWED THAT THE CATHETER MOVED FROM THE T1 POSITION TO THE T8 POSITION. THE HCP SUSPECTED THAT THE PATIENT'S SYMPTOMS WERE POSSIBLY RELATED TO THE CATHETER MIGRATION. THE PATIENT'S SYMPTOMS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013. ADDITIONAL INFORMATION WAS REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95811 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR Hospitalization