BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2884002 · Received December 21, 2012

    Report

    Report Number
    3004209178-2012-12176
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL: 8703W, LOT# L69617, EXPLANTED: UNK. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS IN THE HOSPITAL SINCE A COUPLE OF DAYS AND THE HEALTHCARE PROVIDER (HCP) WAS WORRIED ABOUT A 'POTENTIAL OVERDOSE.' PATIENT WAS REPORTED TO BE UNRESPONSIVE AND RESPONDED 'SOMEWHAT' TO NARCAN. IT WAS INDICATED THAT THIS WAS A 'PAIN PUMP;' DRUG DELIVERED VIA THE DEVICE WAS NOT REPORTED. THE PUMP WAS STOPPED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: PREVIOUSLY REPORTED UNDER MANUFACTURER REPORT # 3004209178-2012-12175 THE PATIENT HAD "NO BLOOD PRESSURE," WAS IN THE ICU AND ON A "DOPAMINE DRIP" AFTER "NARCOTIC OVERDOSED;" HAS BEEN MERGED, ANY NEW INFORMATION WILL BE REPORTED UNDER MANUFACTURER REPORT # 3004209178-2012-12176.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| O