BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2944076 · Received February 5, 2013

    Report

    Report Number
    3007566237-2013-00374
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 13, 2013
    Report Date
    January 21, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. A PUMP REPLACEMENT WAS REPORTED LAST ON (B)(6)DUE TO REPORTED PUMP ALARM. FAMILY REPORTED THE PUMP ALARM WENT OFF AFTER AN MRI. PATIENT WAS DOING FINE POST PUMP REPLACEMENT. SYSTEM USED TO DELIVER SALINE, HOWEVER IT WAS REPORTED MORPHINE WAS GOING TO BE FILLED WITHIN A COUPLE OF DAYS.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT HAD AN MRI ON (B)(6) 2013; A MOTOR STALL FOLLOWED BY A MOTOR STALL RECOVERY WAS NOTED IN THE EVENT LOGS THAT DAY. THE HEALTH CARE PROVIDER (HCP) INTERROGATED THE PUMP AND SAW A MOTOR STALL MESSAGE OCCURRED IN THE LOGS ON (B)(6) 3013. THE HCP WAS UNSURE OF THE CAUSE AND IT WAS REPORTED THE PATIENT WAS AT HOME DURING THAT TIME. THE PUMP WAS INTERROGATED ON (B)(6) 2013 DUE TO THE PATIENT REPORTING HEARING A CRITICAL ALARM, AT WHICH TIME THE MOTOR STALL FROM (B)(6) 2013 WAS DISCOVERED. IT WAS REPORTED ON (B)(6) 2013 A TUBE SET MESSAGE OCCURRED. NO MOTOR STALL RECOVERY WAS NOTED IN THE EVENT LOGS SINCE (B)(6) 2013. IT WAS REPORTED THE PATIENT HAD NO CHANGE IN SYMPTOMS BUT IT WAS NOTED THE DEVICE SYSTEM WAS DELIVERING A LOW DOSE OF MORPHINE AND THAT THE PATIENT HAD ORAL MEDICATIONS IF NEEDED. THE HCP PLANNED TO WAIT A FEW DAYS TO SEE IF RECOVERY OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49028 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR