BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4093500 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17123
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    August 23, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, 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 PRESENTED IN THE ER (EMERGENCY ROOM) AND THEY WANTED THE PUMP OFF DUE TO ¿TOXICITY.¿ THE REPORTER DID NOT KNOW OF ANY RECENT CHANGES TO THE PUMP THAT COULD BE ATTRIBUTED TO THE CHANGE IN THERAPY. THE REPORTER NOTED THAT THE PATIENT WAS HYPOTENSIVE, BRADYCARDIA, LETHARGIC, AND DIFFICULT TO AROUSE; THE PATIENT HAD "ALL OF THE OVERDOSE SYMPTOMS EXCEPT SEIZURE". THE REPORTER WAS REDIRECTED TO THE PATIENT¿S MANAGING PHYSICIAN. THE PUMP WAS BEING USED TO DELIVER BACLOFEN (UNKNOWN). NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP WAS 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
    571152 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR