BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202639 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00477
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 20, 2012
    Report Date
    June 21, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. PRODUCT ID: 8709, LOT# J10956R35, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PUMP WAS GIVING HER PROBLEMS. THE PUMP WOULD GIVE THE DOCTOR BACK THE MEDICINE INSTEAD OF GIVING IT TO THE PATIENT. THE PATIENT¿S LAST REFILL WAS ON (B)(6) 2012 AND AT THAT TIME IT WAS NOTED THAT THE PATIENT ONLY HAD A FEW MONTHS LEFT ON THE PUMP. ON (B)(6) 2012, THE PUMP STARTED TO SOUND A NON-CRITICAL ALARM ¿EVERY TWO TO FOUR HOURS.¿ THE PATIENT WAS NOT FEELING ANY KIND OF WITHDRAWAL SYMPTOMS, BUT REPORTED AS BEING ¿EXHAUSTED.¿ THE DRUGS IN THE PUMP WERE CLONIDINE, BACLOFEN, DILAUDID, AND MARCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302191 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention