BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2761261 · Received September 26, 2012

    Report

    Report Number
    3004209178-2012-08574
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 6, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8711, LOT# J10872R23, IMPLANTED: 2001 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THERE WAS NO APPARENT CAUSE FOR THE VOLUME DISCREPANCY. IT WAS INDICATED THAT THE PATIENTS PUMP WOULD BE REPLACED. AT FIRST THE PHYSICIAN WAS UNABLE TO ASPIRATE FROM THE CATHETER ACCESS PORT. FOLLOWING THAT, HE OPENED THE POCKET AND DISCONNECTED THE CATHETER AND WAS UNABLE TO ASPIRATE FROM THE CATHETER AS WELL. IT WAS INDICATED THAT THE CATHETER WAS LOWERED AND A FEW DROPS OF FLUID CAME OUT. THEY ATTEMPTED TO ASPIRATE AGAIN WHILE THE CATHETER WAS IN THAT POSITION BUT WAS UNSUCCESSFUL. IT WAS STATED THAT THE PATIENT STARTED COMPLAINING OF NOT GETTING THERAPY. IT WAS REPORTED THAT THE PUMP WAS AT FIRST OVER-INFUSING AND NOW UNDER-INFUSING, "LIKE 2 PERCENT." THE OUTCOME OF THE PATIENT WAS NOT PROVIDED. THE DRUGS DELIVERED VIA PUMP WERE MORPHINE AND CLONIDINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THE PATIENT COMPLAINED HE WAS NOT RECEIVING THE CORRECT AMOUNT OF MEDICATION AND DURING REFILLS THERE WAS MORE MEDICATION IN THE RESERVOIR THAN SHOULD BE. THE PUMP WAS REPLACED AND PATIENT WAS DOING WELL HOWEVER THERE WERE COMPLICATIONS WITH OXYGEN SATURATION LEVELS DURING SURGERY SINCE THE PATIENT IS A HEAVY SMOKER AND OVER-WEIGHTED AND NEEDED INTUBATION AND HIS LUNGS SUCTIONED. PUMP HAD NOT BEEN RETURNED AT THE TIME OF THIS REPORT SINCE HOSPITAL DID NOT ALLOW THE COMPANY TO SEND IT TO THEIR PATHOLOGY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A VOLUME DISCREPANCY. THE ACTUAL RESIDUAL VOLUME (ARV) WAS LESS THAN THE EXPECTED RESIDUAL VOLUME (ERV). THE REPORTER WAS UNABLE TO PROVIDE SPECIFIC VALUES FOR VOLUMES, OR ANY FURTHER EVENT DETAIL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention