BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1061419 · Received June 17, 2008

    Report

    Report Number
    3004209178-2008-03308
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP ONLY RETURNED. PRELIMINARY DEVICE ANALYSIS WAS NOT COMPLETED AS OF THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NEVER EXPERIENCED A THERAPEUTIC EFFECT FROM THE DEVICE EVEN AFTER INCREASED DOSAGE. THE DRUG IN THE PUMP WAS DILAUDID 20.0 MG/DL AT A DOSE OF 5.996 MG/DAY AND BUPIVACAINE 2.1 MG/DL AT A DOSE OF 0.6296 MG/DAY. THE HCP PERFORMED A CATHETER DYE STUDY AND COULD NOT ASPIRATE THE CATHETER. A BOLUS WAS THEN FORCED THROUGH THE CATHETER WITHOUT ANY SYMPTOMS OF OVERDOSE. THE HCP NOTED A VOLUME DISCREPANCY EXPECTING TO PULL BACK 5 ML AND PULLED BACK 20 ML. TWO ROLLER STUDIES WERE PERFORMED RESULTING IN THE FIRST STUDY ROLLERS WERE NOT SEEN TURNING, BUT WERE TURNING ON THE SECOND STUDY. AN MRI WAS CONDUCTED WITH RESULTS INDICATING THE CATHETER TIP WAS AT T8-9, BUT THE TIP WAS NOT SEEN WELL. THERE WAS NO EVIDENCE OF A MASS WITHIN THE SUBARACHNOID OR EPIDURAL SPACES TO SUGGEST GRANULOMA FORMATION. NO FINDINGS OF ASSOCIATED OSTEOMYELITIS OR NEOPLASM. THE HCP THUS SUSPECTED A KINKED CATHETER. A REVISION WAS SCHEDULED TO CORRECT THE ISSUE. NO OTHER SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED A ROTOR AND DYE STUDY WERE PERFORMED AND WERE NORMAL. THE SIDE PORT WAS DIFFICULT TO INJECT. THE PUMP WAS REPLACED IN 2008. SEE MFR REPORT # 6000030200802735.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER MODEL 8840 LOT# UNKNOWN