BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1080191 · Received July 22, 2008

    Report

    Report Number
    3004209178-2008-04218
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    PENDING
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE SERIAL NUMBER OF THE DEVICE IS INCLUDED IN THE SYNCHROMED II MISSING PROPELLANT RECALL AND PHYSICIAN COMMUNICATION DATED MAY 21, 2008.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED BOTH OVERDOSE AND UNDERDOSE SYMPTOMS. THE PATIENT WAS VERY RIGID AND DISTRESSED. THE PATIENT NEEDED INTENSIVE CARE FOR RESPIRATORY SUPPORT. NO PUMP RESERVOIR DISCREPANCIES WERE NOTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R IMPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNK| CATHETER: MODEL CATHETER, LOT# UNK| EXPLANTED: