BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II INFUSION PUMP

    MDR report key: 2003240 · Received February 20, 2011

    Report

    Report Number
    MW5019497
    Event Type
    Injury
    Date Received
    February 20, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 20, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MY WIFE HAS BEEN EXHIBITING SYMPTOMS OF A PUMP FAILURE/UNDERDOSE OF THE MEDTRONIC SYNCHROMED II IMPLANTABLE INFUSION PUMP. MODEL NUMBER-8637-40 CATHETER MODEL 8709SC. A DYE TEST WAS DONE ON (B)(6) 2011 AND DETERMINED THAT THE CATHETER WAS BLOCKED OR DISLODGED FROM THE PUMP, THAT THE DYE WAS LEAKING INTO THE POCKET AROUND THE PUMP. HER NEUROLOGIST MONITORING TREATING HER REFERRED HER TO THE HOSPITAL WHERE SHE HAD THE PUMP IMPLANTED FOR REMOVAL AND REPLACEMENT. THE MEDTRONIC REP REQUESTED ANOTHER DYE TEST BEFORE REMOVAL. HIS RECOMMENDATIONS TO US AND THE SURGEON WAS NOT TO REMOVE THE PUMP, THAT EVERYTHING WAS WORKING PROPERLY, AND THAT THE FIRST TEST WAS A BAD TEST. ADDITIONALLY, HE RECOMMENDED TO US, AND THE SURGEON, THAT THE "WITHDRAWAL" SYMPTOMS WERE MORE THAN LIKELY ATTRIBUTABLE TO SOMETHING OTHER THAN THE PUMP MALFUNCTIONING. I REQUESTED A VOLUME TEST TO ENSURE IT WAS ADMINISTERING THE PROPER AMOUNT, AND MY REQUEST WAS DENIED BY THE MEDTRONIC REP, QUOTING: "THERE IS NO NEED". SHE'S HAD THE PUMP IMPLANTED SINCE (B)(6) 2010, AND THE SYMPTOMS AROSE AFTER THE LAST REFILL IN (B)(6) 2010, (B)(6) 2011. I DO NOT REMEMBER THE EXACT DATE, AND THE MEDTRONIC REP WILL NOT PROVIDE ME WITH THE HISTORY OF THE REFILL NOR THE PRINTOUT OF THE STATUS OF THE PUMP. DATES OF USE: (B)(6) 2010 TO CURRENT. DIAGNOSIS OR REASON FOR USE: SPASTICITY. EVENT NOT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II INFUSION PUMP INFUSION PUMP, 117CC LKK MEDTRONIC, INC. 8637-40
    2 SYNCHROMED II INFUSION PUMP CATHETER LKK MEDTRONIC, INC. 8709SC

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| O| S