BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3243380 · Received July 23, 2013

    Report

    Report Number
    3007566237-2013-02456
    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

    CONCOMITANT PRODUCT: 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)(6) 2013 NOT (B)(6) 2013.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A REFILL CLOSE TO THE FEBRUARY IMPLANT OF THE NEW DEVICE AN OVERDOSE WAS SUSPECTED. THE PATIENT REPORTEDLY WAS HOSPITALIZED. REPORTEDLY THE SEIZURE MEDICATION THE PATIENT TAKES MAKES THE PATIENT DROWSY ANDTHIS 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.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD A SEIZURE AND NOT AN OVERDOSE ON (B)(6) IN THE OFFICE. IT HAD NEVER BEEN DETERMINED WHAT CAUSED IT BUT IT WAS NOT THE PUMP NOR THE MEDICATION AS FAR AS THE PHYSICIAN COULD TELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342221 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| O