BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4894515 · Received July 7, 2015

    Report

    Report Number
    3004209178-2015-12858
    Event Type
    Injury
    Date Received
    July 7, 2015
    Report Date
    June 16, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8590-1, LOT # N151979, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY; PRODUCT ID 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) LAST WEEK WITH TREMORS AND SEIZURE LIKE ACTIVITY. THE PATIENT BLAMED THE SYMPTOMS ON THE PUMP. IT WAS NOTED THAT SALINE WAS PRESENT IN THE PUMP AT THE TIME, AND THE HEALTH CARE PROVIDER (HCP) MENTIONED THAT THERE WAS NO CONNECTION BETWEEN THE PATIENT ISSUES AND THE PUMP. NO OTHER MEDICAL DIAGNOSIS WAS DETERMINED AS A CAUSE FOR THE EVENT. AT THE TIME OF THIS REPORT, THE PATIENT HAD NO FURTHER SYMPTOMS. IF ADDITIONAL INFORMATION IS RECEIVED THE REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM AN HCP. THE PATIENT HAD AN IMPLANTED DILAUDID PUMP. THE PUMP WAS STOPPED (B)(6) 2015. THE PATIENT RECEIVED NO MEDICATIONS VIA THE PUMP; IT WAS SLOWLY TAPERED BEFORE DISCHARGE (D/C). THE PATIENT HAD SALINE (PRESERVATIVE FREE) SOLUTION IN THE PUMP AT THE TIME OF THE DISCOMFORT; THE PATIENT WAS INITIALLY PLACED ON SALINE INFUSION ON (B)(6) 2015. THE PATIENT INDICATED ON (B)(6) 2015 NO SEQUELAE TO HER HOSPITALIZATION. THE CAUSE OF THE EVENT WAS THAT SHE HAD A SMALL AMOUNT OF THE CATHETER DILAUDID, WHICH WAS INFUSED WHEN THEY STARTED SALINE INFUSION ON (B)(6) 2015. IT WAS POSSIBLE THE PATIENT HAD "SLIGHT" WITHDRAWAL, AND HAD NO SEQUELAE TO THE EVENTS. THE EVENT WAS QUESTIONED TO BE ATTRIBUTED TO DRUG EFFECTS OF POSSIBLE SHORT TERM WITHDRAWAL. THE PATIENT WAS SLOWLY TAPERED OVER SEVERAL WEEKS. NO TROUBLESHOOTING, INTERVENTIONS OR OTHER ACTIONS WERE TAKEN. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE PATIENT HAD NO SEQUELAE TO THE STOPPED PUMP; IT WAS DONE SLOWLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440528 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization