BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3243260 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12186
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 19, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORTED FILED TO CORRECT THE ALERT DATE FOR THE INFORMATION RECEIVED FOR THE SUPPLEMENTAL 1 REPORT. THE DATE THE MANUFACTURER BECAME AWARE OF THE PHYSICIAN'S ADDITIONAL INFORMATION WAS (B)(4) 2013.

    Description of Event or Problem · 1

    ADDITIONALLY, ONE OF THE PATIENT'S PHYSICIAN NOTED THAT THIS EVENT HAD NOT BEEN DOCUMENTED ANYWHERE WHILE UNDER THIS PHYSICIAN¿S CARE. THIS PHYSICIAN HAD NO RECORD OF THIS NOR ANY FURTHER INFORMATION TO PROVIDE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A REFILL IN (B)(6) 2012 AN OVERDOSE WAS SUSPECTED. THE PATIENT REPORTEDLY WAS HOSPITALIZED. REPORTEDLY THE SEIZURE MEDICATION THE PATIENT TAKES MAKES THE PATIENT DROWSY AND THIS MIMICS THE OVERDOSE SYMPTOMS. THIS DEVICE SYSTEM DELIVERED BACLOFEN AND DILAUDID. 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
    343166 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| O