BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2244026 · Received August 24, 2011

    Report

    Report Number
    3004209178-2011-06808
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 1, 2011
    Manufacturer
    MDT PUERTO RICO OPEARTIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT AN ALARM WAS HEARD FOLLOWING A PATIENT'S HYPERBARIC THERAPY. THE ALARM WAS NOT CONFIRMED VIA TELEMETRY. THE ALARM OCCURRED EVERY 3 MINUTES FOR 10 TO 15 MINUTES. IT WAS FURTHER NOTED THAT THE ALARM HAD NOT BEEN HEARD SINCE. NO ALARM WAS RECORDED IN THE PUMP LOGS. THE PATIENT DID NOT HAVE A CHANGE IN SYMPTOM CONTROL. IT WAS INDICATED THAT THE PATIENT HAS HAD SEVERAL HYPERBARIC TREATMENTS WITHOUT ISSUE. IT WAS LATER REPORTED THAT A PUMP FAILURE OCCURRED IN REGARDS TO BATTERY DEPLETION. THE PATIENT EXPERIENCED A LOSS OF PAIN RELIEF. REPORTED PUMP MEDICATION INFORMATION WAS UNCLEAR, HOWEVER "OTHER" WAS SPECIFIED (LIORESAL, COMPOUNDED BACLOFEN, AND GABALON WERE NOT INDICATED). THE PATIENT WAS WITHOUT INJURY. ADDITIONAL INFORMATION WILL BE PROVIDED IN A FOLLOW UP REPORT, AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPEARTIONS CO., JUNCOS 8637-40 MA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR IMPLANTED:| CATHETER: MODEL 8709, LOT# J11787R34| EXPLANTED: