BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 6118805 · Received November 21, 2016

    Report

    Report Number
    3004209178-2016-24498
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 21, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS RECEIVING HYDROMORPHONE (UNKNOWN CONCENTRATION AND DOSE) VIA AN IMPLANTABLE PUMP. INDICATION FOR USE WAS NON-MALIGNANT PAIN. THE DATE OF THE EVENT WAS (B)(6) 2016. IT WAS REPORTED A PUMP ALARM OCCURRED ON (B)(6) 2016 AND WAS A SINGLE BEEP. THE PATIENT HAD BEEN SCHEDULED FOR A PUMP REFILL (B)(6) 2016 BUT IT WAS CANCELLED BECAUSE THE PHYSICIAN OFFICE WAS CLOSED. THE PATIENT WAS TO FOLLOW UP ON 10/27/2016 BUT WAS STUCK IN TRAFFIC AND DID NOT MAKE IT TO THE APPOINTMENT. THE PATIENT CONTACTED THE HEALTHCARE PROFESSIONAL (B)(6) 2016 AND SPOKE WITH THE CLINIC (B)(6) 2016. THE PATIENT HAS AN APPOINTMENT SCHEDULED FOR (B)(6) 2016. THE PATIENT HAD A ¿MILLION SURGERIES¿; DATES UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769025 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR