BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3134031 · Received May 29, 2013

    Report

    Report Number
    6000030-2013-00125
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT# J0177967R, IMPLANTED: (B)(6) 2001, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL DUE TO INCREASED DEPRESSION. THE PATIENT WAS IN THE PSYCHIATRIC UNIT. IT WAS REPORTED THAT THE HOSPITALIZATION WAS UNRELATED TO THE DRUG INFUSION SYSTEM; HOWEVER, THE INFORMATION WAS SPECULATIVE AND THERE WAS NO ALTERNATIVE CAUSE FOR THE DEPRESSION REPORTED. THE STAFF THOUGHT THAT THE PATIENT¿S PUMP NEEDED TO BE REFILLED AND A MANUFACTURER¿S REPRESENTATIVE WAS PAGED TO READ THE PUMP. THE PUMP DISPLAYED A LOW BATTERY ALARM MESSAGE. THE ALARM HAD NOT BEEN HEARD BY THE PATIENT. THE PUMP WAS SCHEDULED TO BE REPLACED IN TWO WEEKS, BUT IT WAS UNSURE IF THE SURGERY DATE WOULD BE HELD DUE TO THE PATIENT BEING ADMITTED. IT WAS CONFIRMED THAT THE RESERVOIR VOLUME WAS 5.7 ML. THE LOW RESERVOIR ALARM DATE WAS IN 24 DAYS. THE DEVICE SYSTEM WAS USED TO DELIVER BUPIVACAINE AND MORPHINE. 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
    236860 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627-18

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization