BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3784367 · Received May 1, 2014

    Report

    Report Number
    3004209178-2014-08350
    Event Type
    Injury
    Date Received
    May 1, 2014
    Report Date
    April 8, 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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID 8575, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8780, LOT# 0206882558, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 870953, SERIAL# (B)(4), PRODUCT TYPE: CATHETER.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# UNKNOWN, EXPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID 8575, PRODUCT TYPE: ACCESSORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED SPASTICITY AS THE LEG SPASTICITY WAS NOT WELL CONTROLLED. THE SURGEON UNSURE HOW WELL THE SYSTEM WAS WORKING DUE TO REFILL DISCREPANCIES SO THE CATHETER WAS REPLACED AT THE TIME OF A ROUTINE BATTERY/ PUMP REPLACEMENT. THE PUMP WAS REPROGRAMMED AS IT WAS DECIDED TO REDUCE THE DAILY DOSE TO 400 MICROGRAMS (MCG) PER DAY. THE EXPECTED RESERVOIR VOLUME (ERV) WAS 2 MILLILITERS (ML) BUT THE ACTUAL RESERVOIR VOLUME (ARV) WAS 6 ML. IN ADDITION, THERE WAS REPORT THAT AT REFILLS THEY WERE GETTING BETWEEN 2 TO 6 ML MORE BACK. A CATHETER OCCLUSION WITH AN UNKNOWN LOCATION WAS REPORTED. THE CATHETER WAS EXPLANTED FROM T12 AND THE NEW CATHETER WAS INSERTED AT ANOTHER LEVEL AT ABOUT T6 AS THE PATIENT HAD SPINAL HARDWARE. IT WAS UNKNOWN IF THERE WAS ANY TROUBLESHOOTING OR DIAGNOSTIC TESTING, IF THE ISSUE WAS RESOLVED OR IF THE CAUSE WAS DETERMINED. AT THE TIME OF THE EVENT, THE PATIENT'S STATUS WAS REPORTED AS ALIVE-NO INJURY. THIS DEVICE SYSTEM DELIVERED LIORESAL. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PUMP MODEL 8626-10 WAS AN "OLD" PUMP, AND LIKELY THE PATIENT'S FIRST PUMP. ON (B)(6) 2014, THE PATIENT HAD AN 8637-20 PUMP REPLACED (LIKELY THEIR SECOND PUMP) FOR THE PREVIOUSLY REPORTED NORMAL BATTERY DEPLETION, WITH PUMP 8637-40 (LIKELY THE PATIENT'S THIRD PUMP). WITH REGARD TO THE CATHETERS: THE 8709 CATHETER (WITH THE 8575 CONNECTOR) WAS PREVIOUSLY REPORTED TO HAVE BEEN REMOVED ON (B)(6) 2014, AND WAS REPLACED WITH AN UNKNOWN CATHETER (SERIAL NUMBER (B)(4)). IT WAS NOTED THAT THE EXPLANTED 8709 CATHETER AND PUMP MODEL 8637-20 WERE EXPLANTED, BUT IT WAS UNKNOWN IF THEY WERE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263714 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention