BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4692965 · Received April 15, 2015

    Report

    Report Number
    3007566237-2015-00990
    Event Type
    Injury
    Date Received
    April 15, 2015
    Date of Event
    March 20, 2015
    Report Date
    March 23, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S PUMP WAS SOUNDING ALARMS EVERY 5 MINUTES AND THEY HAD WITHDRAWAL SYMPTOMS. THE PUMP WAS INTERROGATED AND THE FOLLOWING MESSAGES WERE NOTED; STOPPED PUMP PERIOD MAY EXCEED TUBE SET, PUMP IN SAFE STATE, RESET OCCURRED ((B)(6) 2015 20:39, 20:44, 20:49, 20:54, 20:59, 21:04, 21:09, 21:26, 21:31, 21:36, 21:41, 21:46, 21:51, 21:56, 22:01), RESET OCCURRED - LOW BATTERY ((B)(6) 2015 20:39, 20:44, 20:49, 20:54, 20:59, 21:04, 21:09, 21:26, 21:31, 21:36, 21:41, 21:46, 21:51, 21:56, 22:01), MOTOR STALL OCCURRED. THE PATIENT WAS HOSPITALIZED FOR A REVIEW OF THE SYSTEM. A ROLLER STUDY WAS PERFORMED ON (B)(6) 2015 AND SHOWED THE ROLLERS WERE ARRESTED. THE PATIENT WAS NOT RECEIVING THERAPY FROM THE PUMP AND WAS WAITING FOR A PUMP REPLACEMENT. CONFLICTING INFORMATION ALSO REPORTED THE PUMP'S EXPLANT/REVISION DATE WAS (B)(6) 2015 AND "REMAINS IN PATIENT." THERE WERE NOT ANY ELECTROMAGNETIC INTERFERENCE (EMI) SOURCES NEARBY WHEN THE ALARM WAS NOTICED. THE PUMP WAS USED TO DELIVER MORPHINE. THE OUTCOME OF THE EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250373 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention