BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3913255 · Received July 3, 2014

    Report

    Report Number
    3007566237-2014-01872
    Event Type
    Injury
    Date Received
    July 3, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED AN UNEXPLAINED EVENT IN THE EXCEPTION HISTORY LOG. THE FOLLOWING WAS DETECTED ¿(12H)EEPROM UNCORRECTABLE ERROR DETECTED, (1BH) MOTOR PULSE PARAMETER DATA RESTORED FROM ROM, AND (1AH) MOTOR PULSE PARAMETER RESTORED FROM EEPROM¿. THE HYBRID WAS REMOVED FROM THE PUMP AND SENT FOR FURTHER TESTING. NO SIGNIFICANT ANOMALIES WERE FOUND WITH THE PUMP. ADDITIONAL ANALYSIS RESULTS WILL BE ADDED TO THIS EVENT IF A PROBLEM IS FOUND WITH THE HYBRID. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT INITIALLY IT TOOK ALMOST A YEAR TO ADJUST DOSE.

    Description of Event or Problem · 1

    THE PATIENT TOLD THEIR MANAGING PHYSICIAN THAT THEY BELIEVED THEY WERE PART OF A RECALL ON THE PUMP. THEY HAD BEEN HAVING DIMINISHED RESULTS FROM THE PUMP OVER TIME AND REPORTED LESS THAN 50% THERAPY RELIEF. A COUPLE OF CATHETER ACCESS PORT (CAP) ASPIRATIONS WERE PERFORMED OVER THE LAST FEW MONTHS, AND THEY HAD BEEN ABLE TO GET BACK CEREBROSPINAL FLUID (CSF) WITHOUT ANY PROBLEM. THE MANAGING PHYSICIAN STATED THAT THE DOSE HAD TO BE INCREASED FROM 300 MCG/DAY TO 400 MCG/DAY. THE PUMP WAS TO BE REPLACED ON (B)(6) 2014. THEIR STATUS AT THE TIME OF THE REPORT WAS ALIVE WITH NO INJURY. THE MEDICATION INFUSED WAS LIORESAL. ON (B)(6) 2014 INFORMATION WAS RECEIVED FROM A REPRESENTATIVE INDICATING THE PATIENT HAD EXPERIENCED INCREASED TONE. THE PUMP WAS REPLACED WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390111 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention