BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1032917 · Received April 23, 2008

    Report

    Report Number
    6000030-2008-02157
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    January 16, 2008
    Report Date
    March 26, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - OTHER: FINAL DEVICE ANALYSIS REVEALED MOTOR GEAR SHAFT WEAR. THE SERIAL NUMBER IS INCLUDED IN THE RANGE FOR SYNCHROMED EL PUMP MOTOR STALL DUE TO GEAR SHAFT WEAR MFG BEGINNING SEPT 1999, PHYSICIAN COMMUNICATION (DATED AUG. 2007).

    Description of Event or Problem · 1

    THE PUMP WAS EXPLANTED AND REPLACED DUE TO BATTERY DEPLETION. A ROTOR STUDY WAS NOT PERFORMED. THE PUMP WAS USED TO DELIVER LIORESAL. NO SYMPTOMS WERE REPORTED. THE HCP REPORTED THE PT OUTCOME AS 'NO INJURY, RECOVERED WITHOUT SEQUELA'.

    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 UNK IMPLANTED| PROGRAMMER MODEL PROGRAMMER LOT#UNK| IMPLANTED| EXPLANTED| CATHETER MODEL 8709 LOT# J11774R20| EXPLANTED