BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3030705 · Received April 2, 2013

    Report

    Report Number
    3007566237-2013-00975
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS THAT ON (B)(6) 2013 THE PUMP WAS REFILLED AND SHOWED AN ELECTIVE REPLACEMENT INTERVAL (ERI) OF 5 MONTHS. ON (B)(6) 2013 THE PATIENT INFORMED THE HEALTH CARE PROVIDER (HCP) OF WITHDRAWAL SYMPTOMS. THE PUMP WAS INTERROGATED AND WAS NOTED TO BE AT THE MINIMUM RATE. INITIALLY, IT WAS UNCLEAR IF A PATIENT HAD A MAGNETIC RESONANCE IMAGING (MRI) SCAN. HOWEVER, IT WAS LATER CONFIRMED THAT THE PATIENT HAD AN MRI ON (B)(6) 2012. IT WAS NOT KNOWN IF THE PUMP WAS CHECKED AFTER A (MRI) SCAN OR IF THE LOGS WERE CHECKED CORRECTLY ON THAT DAY. THE PUMP LOGS WERE NOW FURTHER REVIEWED. THE (B)(6) 2013 INTERROGATION REVEALED NO MOTOR STALL WAS SEEN AND IT APPEARED AS A NORMAL PUMP REFILL. HOWEVER, ON (B)(6) 2013 AT 09:51 AN INFUSION BOLUS WAS PROGRAMMED AND THEN AT 09:53 A LOW BATTERY RESET AND SAFE STATE CONDITION HAD OCCURRED. A MOTOR STALL RECOVERY ON (B)(6) 2013 WAS ALSO NOTED. IT WAS REPORTED THAT WHILE INTERROGATING THE DEVICE ON (B)(6) 2013 A POP UP WINDOW WAS NOT RECALLED BY THE INTERROGATOR. ON (B)(6) 2013 THE PUMP WAS PROGRAMMED BACK TO SIMPLE CONTINUOUS. THE PATIENT'S DOSE HAD TITRATED A FEW TIMES SINCE (B)(6) 2013 AS THE PATIENT HAD BEEN ON A HIGH DOSE PREVIOUSLY. THE LAST PUMP UPDATE WAS (B)(6) 2013 AND THE PUMP WAS STILL IN A SIMPLE CONTINUOUS INFUSION. THE PATIENT FELT MUCH BETTER AND THE PAIN HAD IMPROVED. IT WAS UNKNOWN AT THAT TIME IF THE DEVICE WAS TO BE REPLACED. IT WAS LATER REPORTED THAT THE PATIENT HAD REPORTED WITHDRAWAL TYPE SYMPTOMS WHICH WERE NOT SPECIFIED. THE PUMP HAD BEEN GRADUALLY INCREASED OVER A FEW DAYS. AS OF (B)(6) 2013 THE PUMP SHOWED NO SIGNS OF STALLING. THE LOGS SHOWED A LOW BATTERY ALARM, A MOTOR STALL RECOVERY (NO MOTOR STALL IN EXISTING LOGS), AND A SAFE STATE MESSAGE. THE PUMP WAS TO BE REPLACED SOON AND RETURNED FOR ANALYSIS. THIS DEVICE SYSTEM DELIVERED MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134746 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention