BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3256433 · Received July 31, 2013

    Report

    Report Number
    3004209178-2013-12554
    Event Type
    Injury
    Date Received
    July 31, 2013
    Report Date
    July 9, 2013
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8590-1 LOT# N233815, IMPLANTED: 2010 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN CRITICAL PUMP ALARM OCCURRED. THE PATIENT REPORTED A MYOCARDIAL INFARCTION (MI) AROUND THE TIME OF THE CRITICAL ALARM AND AS A RESULT MISSED HER REFILL APPOINTMENT. THE PATIENT HAD PAIN, CHEST PAIN AND NAUSEA. THE LOCATION OF THE SYMPTOMS WAS REPORTED AS PANCREAS. THE PUMP WAS REFILLED. THE DEVICE SYSTEM DELIVERED DILAUDID, BUPIVACAINE AND CLONIDINE. IT WAS LATER REPORTED THAT THE PATIENT HAD NO FURTHER COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358565 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Life Threatening