BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4241321 · Received November 10, 2014

    Report

    Report Number
    3004209178-2014-21252
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 20, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER RECEIVED REPORTED THAT IT WAS NOT KNOWN IF THERE WERE ANY SYMPTOMS RELATED TO THE EVENT. EOS OCCURRED, NORMALLY. THERE WAS NO TROUBLESHOOTING OR OTHER ACTIONS TAKEN TO RESOLVE THE EVENT. THE HCP TRIED TO CONTACT THE PATIENT¿S SON TO GET THE PATIENT IN EARLIER, THE PATIENT LIVES IN ECF (EXTENDED CARE FACILITY). THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    THEY WERE WEANING THE PATIENT OFF OF THE INTRATHECAL BACLOFEN AND SWITCHING TO PRESERVATIVE FREE NORMAL SALINE. THEY NOTED THE ERI (ELECTIVE REPLACEMENT INDICATOR) HAD OCCURRED, BUT WERE CONFUSED AS THE EOS (END OF SERVICE) HAD ALREADY OCCURRED ON (B)(6) 2014. THE DEVICE SYSTEM WAS DELIVERING GABLOFEN. THE INTERVENTIONS AND OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723490 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR