BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1242950 · Received November 21, 2008

    Report

    Report Number
    3004209178-2008-07658
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 27, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP HAD FLIPPED. A POCKET REVISION WAS PERFORMED. DURING THE REVISION THE HEALTH CARE PROFESSIONAL HAD DIFFICULTY ASPIRATING THROUGH THE CATHETER ACCESS PORT (CAP) THE HCP REMOVED THE SUTURELESS CONNECTOR FROM THE PUMP AND ATTEMPTED TO ASPIRATE DIRECTLY FROM THE CAP AND AGAIN MET WITH RESISTANCE. THE HCP THEN DECIDED TO INJECT PRESERVATIVE FREE NORMAL SALINE THROUGH THE CAP, STILL MET WITH SOME RESISTANCE. THE HCP STATED THAT IT FELT LIKE SOMETHING WAS CLEARED". THE SUTURELESS CONNECTOR WAS REATTACHED TO THE PUMP AND THERE WAS NO FURTHER DIFFICULTY IN ASPIRATING THROUGH THE CAP. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS. THE PATIENT'S CURRENT STATUS IS 'WITHOUT ANY PROBLEMS'. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention EXPLANTED:| ACCESSORY: MODEL 8590-1| EXPLANTED:| CATHETER: MODEL 8709SC| PROGRAMMER: MODEL 8840