BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3102660 · Received May 9, 2013

    Report

    Report Number
    3007566237-2013-01566
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    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 REPORTED THE CRITICAL ALARM WAS HEARD ONCE THE DAY PRIOR TO THIS REPORT AND THREE TIMES ON THE DAY OF THIS REPORT. THE NIGHT PRIOR TO THIS REPORT, THE PATIENT HAD LEG SPASTICITY THAT WASN'T EXPERIENCED "IN YEARS." UPON PUMP INTERROGATION, IT SHOWED A MOTOR STALL, WITHOUT RECOVERY, AND A TUBE SET MESSAGE HAD OCCURRED. THE PUMP LOG SHOWED A STALL ON (B)(6) 2013 AT 23:23 WITH THE TUBE SET MESSAGE 24 HOURS LATER. THE PATIENT WAS AT HOME AT THE TIME OF THE STALL. THERE WERE NO KNOWN ELECTROMAGNETIC INTERFERENCE (EMI) EXPOSURES, OR RECENT MEDICAL PROCEDURES. THE PATIENT WAS TO BE SUPPLEMENTED WITH ORAL MEDICATION AND HAVE SURGERY "AS SOON AS POSSIBLE." IT WAS NOTED THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS AT FOUR MONTHS AND A PUMP REPLACEMENT WAS PLANNED FOR (B)(6). THE PUMP WAS DELIVERING BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202741 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00021 YR Required Intervention