BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4221652 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20875
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 27, 2014
    Report Date
    October 29, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709, SERIAL # (B)(6), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN. THE EVENT WAS REPORTEDLY NOT ATTRIBUTED TO THE PUMP, CATHETER, PROGRAMMER OR DRUG EFFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT THINKS THEY ARE HAVING A "PUMP FAILURE." THE PATIENT WAS HAVING SEVERE BACK PAIN THAT STARTED 2 DAYS AGO AND HAD SOME NAUSEA. THE LAST REFILL WAS UNKNOWN, THE PATIENT THOUGHT MAYBE (B)(6) 2014. THE PATIENT HAD A DOCTOR'S APPOINTMENT AT ON (B)(6) 2014 AT 2:30PM. THE PATIENT HAD NOT HEARD ANY ALARMS COMING FROM THE PUMP. THE PUMP SYSTEM WAS DELIVERING DILAUDID. (NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703108 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR