BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1181763 · Received September 30, 2008

    Report

    Report Number
    3004209178-2008-06223
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Report Date
    September 4, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER OF THE DEVICE IS INCLUDED IN THE SYNCHROMED II MISSING PROPELLANT RECALL AND PHYSICIAN COMMUNICATION.

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL STATED THE PUMP HAD NOT BEEN WORKING PROPERLY SINCE THE BEGINNING. NO ADDITIONAL DETAILS WERE PROVIDED. THERE WAS NO PATIENT INJURY. THE MEDICATION BEING DELIVERED VIA THE PUMP WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 EXPLANTED:| PROGRAMMER MODEL 8840| CATHETER: MODEL CATHETER