BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3021869 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04256
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PATIENT PROGRAMMER: MODEL 8835, SERIAL# (B)(4), IMPLANTED:NA, EXPLANTED:NA. CATHETER: MODEL 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF COLD SWEATS, "SOME" INCREASED PAIN, THE HEALTHCARE PROVIDER "BELIEVED" IT WAS DUE TO THE DRUG. TROUBLESHOOTING HAD BEEN DONE TO RULE OUT PUMP OR CATHETER ISSUES AND "ALL WAS NEGATIVE", SPECIFIC TROUBLESHOOTING WAS NOT REPORTED. THE DRUG WAS CHANGED. TWO WEEKS LATER IT WAS ADDED THAT THE PATIENT HAD A PANIC ATTACK AND WAS HOSPITALIZED, THE SYMPTOMS SHE EXPERIENCED "THE ENTIRE TIME" WERE DUE TO ANXIETY. IT WAS NOTED THAT ALL NARCOTICS WERE REMOVED FROM THE PUMP AND THE PATIENT WAS "NOW" ON LONG TERM TREATMENT FOR ANXIETY. THE SYMPTOMS ASSOCIATED WITH THE EVENT WERE ANXIETY AND PERSPIRATION. IT WAS NOTED THERE WERE NO INJURIES. THE DEVICE SYSTEM HAD BEEN USED TO INFUSE FENTANYL, HYDROMORPHONE AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124073 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization