BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1232535 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07447
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 17, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS ATTACKED, KNOCKED DOWN AND KICKED. IT WAS THOUGHT THAT THE PUMP WAS COMPROMISED WITH THE ATTACK. THE PUMP WAS INTERROGATED AND FOUND TO BE IN MINIMUM RATE MODE WITH A STATUS OF SAFE STATE/RESET OCCURRED DATED 2008. THE PUMP RESERVOIR WAS DRY. THE PATIENT HAD MISSED THE PUMP REFILL VISIT, BECAUSE IT WAS THE DAY OF THE ATTACK. THE PUMP WAS REPROGRAMMED TO THE CORRECT SETTING. THE PATIENT WAS BEING SUPPLEMENTED WITH ORAL DRUGS UNTIL THE PUMP COULD BE REFILLED. THE PUMP WAS USED TO DELIVER FENTANYL (1500 MCG/ML) AT A RATE OF 9 MCG/DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTIVE REPLACEMENT INDICATOR WAS IN 29 MONTHS WHICH IS LONGER THAN EXPECTED. THE HEALTH CARE PROFESSIONAL WAS ABLE TO "PROGRAM OUT" OF THE SAFE STATE PREVIOUSLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR CATHETER : MODEL 8703W, LOT # L56471| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 8840| CATHETER: MODEL 8711, LOT# UNK| IMPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8711, LOT # N074035027| EXPLANTED: