BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2854735 · Received December 3, 2012

    Report

    Report Number
    3007566237-2012-02895
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER 8709, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6), EXPLANTED: 2009-(B)(6), (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED AN OVERDOSE. THE PATIENT INDICATED THAT THE PUMP WAS "WORKING GOOD" BUT THEN WENT IN FOR A REFILL AND THE NURSE PRACTITIONER DOUBLED THE DOSE. THE PATIENT ENDED UP SEEING THE HCP "WHO KEEPS HIM LIVING". THE PUMP DELIVERED FENTANYL. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE TO US.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: OVERDOSE WAS NOT REPORTED. THE PATIENT HAD THE DOUBLED DOSE IN THEIR PUMP FOR TWO OR THREE DAYS BEFORE IT COULD BE "CUT DOWN" AND IT "RUINED" THE PUMP. THE PUMP WAS REPLACED. 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
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Other