BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3021642 · Received March 26, 2013

    Report

    Report Number
    3007566237-2013-00893
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S ELECTIVE REPLACEMENT INDICATOR (ERI) AND END-OF-SERVICE (EOS) WERE BOTH MISSED DUE TO THE LENGTH OF TIME BETWEEN THE PATIENT'S REFILLS. DURING A REFILL APPOINTMENT ON (B)(6), A MESSAGE TO REPLACE THE PUMP BY (B)(6) WAS SEEN. THE PUMP'S ERI HAD OCCURRED ON (B)(6) 2012, BUT THE PATIENT ONLY GETS FILLED EVERY EIGHT MONTHS, SO IT WASN'T SEEN UNTIL (B)(6). IT WAS STATED THAT THE PATIENT HAD CALLED THE HEALTHCARE PROVIDER (HCP) AND HAD SAID THAT HER PUMP WOULD BEEP ONCE A DAY. LATER, THE PATIENT WOULD HEAR THE BEEPING TWO OR THREE TIMES PER DAY. THE PUMP WAS SCHEDULED TO BE REMOVED ON THE FOLLOWING FRIDAY. ABOUT TWO WEEKS LATER, IT WAS REPORTED THAT THE EVENT WAS DUE TO NORMAL BATTERY DEPLETION AND END-OF-SERVICE. THERE WERE NO SIGNS OR SYMPTOMS BESIDES THE AUDIBLE ALARM. THERE WAS NO PATIENT INJURY, BUT THE PATIENT HAD BEEN HOSPITALIZED DUE TO THE EVENT. THE DRUG USED IN THIS SYSTEM WAS COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123821 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R