BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1040367 · Received May 7, 2008

    Report

    Report Number
    6000030-2008-02456
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 10, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0950-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER IS INCLUDED IN THE RANGE FOR THE SYNCHROMED EL PUMP MOTOR STALL DUE TO GEAR SHAFT WEAR MANUFACTURED BEGINNING 1999 PHYSICIAN COMMUNICATION (DATED 2007). GEAR SHAFT WEAR WAS NOT CONFIRMED IN THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A ROTOR STUDY WHICH REVEALED THAT THE ROTOR WAS NOT TURNING. THE PT'S PUMP WAS PROGRAMMED TO MINIMUM RATE AND THE PT WAS GIVEN A SUPPLEMENT ORAL PAIN MEDICATION UNTIL PUMP REPLACEMENT COULD TAKE PLACE. NO PT SYMPTOMS OR OUTCOME WAS REPORTED. THE DRUG CONTAINED IN THE PT'S PUMP WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO IS RECEIVED.

    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 55 YR EXPLANTED:| CATHETER: MODEL 8709, LOT# J11659R55| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK| IMPLANTED: