BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1832220 · Received September 3, 2010

    Report

    Report Number
    6000030-2010-06758
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 9, 2010
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2010, WITH INCREASED SPASTICITY AND STATED THAT THE PUMP WAS NOT WORKING. THE PT HAD A PUMP REFILL PERFORMED IN (B)(6) 2010, AND IT WAS SUGGESTED AT THAT TIME THAT THE PT'S PUMP NEEDED TO BE REPLACED DUE TO BATTERY DEPLETION. THERE WAS NO AUDIBLE PUMP ALARM HEARD. NO INFORMATION WAS PROVIDED RELATED TO THE CONCENTRATION OR DOSAGE OF MEDICATION USED IN THE PT'S PUMP. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT REC'D AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR EXPLANTED:| CATHETER: MODEL 8703, LOT# J93117931| IMPLANTED: