BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3170273 · Received June 14, 2013

    Report

    Report Number
    3007566237-2013-01982
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REPRESENTATIVE LATER REPORTED THAT THEY MET WITH THE PHYSICIAN IN (B)(6) TO REVIEW THE LATEST RECALL. THEY ALSO REVIEWED HOW TO GET LOGS TO SEE IF AN ALARM ACTUALLY OCCURRED. THE PHYSICIAN WAS GOING TO CHECK AT THE NEXT REFILL AND ALSO PLAY THE ALARM FOR THE PATIENT¿S MOM TO SEE IF SHE COULD HEAR IT.

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER (HCP) REPORTED THAT A REFILL WAS PERFORMED THAT ¿APPARENTLY WENT WELL¿. THE PATIENT¿S APPOINTMENT FOR REFILL WAS THE DAY OF THE REPORT. THE PATIENT¿S LOW RESERVOIR ALARM WAS SET TO 1 ML AT ONCE PER HOUR. THE PATIENT WAS NOTED TO HAVE BEEN BELOW THE LOW RESERVOIR ALARM VOLUME, AND THEY HAD AN EXPECTED RESIDUAL VOLUME OF 0.4 ML. THIS AMOUNT WAS ALSO NOTED TO HAVE BEEN THE AMOUNT THAT THE HCP GOT OUT. THE PATIENT¿S MOTHER DID NOT HEAR ANY ALARMS. THE PATIENT HAD LEFT THE OFFICE, SO IT WAS AGREED TO REVIEW THE ALARMS AND LOGS WITH THE HCP ON (B)(6) 2013. THERE WAS NO INJURY OR DEATH. THE MEDICATION USED WITHIN THE SYSTEM WAS UNKNOWN. THE APPOINTMENT WAS POSTPONED TO THE FOLLOWING WEEK.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE REPRESENTATIVE MET WITH THE HCP (PATIENT NOT PRESENT) TO REVIEW PUMP ALARMS IN GENERAL. THEY STATED AT THE TIME THE PATIENT WAS FINE AND MAY NOT HAVE HEARD THE ALARM SINCE IT ONLY WENT OFF ONCE PER HOUR "THE WAY THE HCP HAD IT SET". THE REPRESENTATIVE SUGGESTED THEY SET THE CRITICAL ALARM FOR EVERY TEN MINUTES, REVIEW THE PUMP LOGS, AND PLAY THE ALARMS FOR THE PATIENT'S MOTHER WHEN THE PATIENT RETURNED. THEY PLANNED TO CHECK BACK WITH THE HCP TO SEE HOW THE PATIENT WAS DOING. THEY DO NOT RECALL THE HCP SAYING THAT THE PATIENT EXPERIENCED ANY SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271628 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1