BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3342380 · Received September 11, 2013

    Report

    Report Number
    3007566237-2013-02971
    Event Type
    Injury
    Date Received
    September 11, 2013
    Report Date
    August 19, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8590-1, LOT# N201724, IMPLANTED: 2009-(B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID 8709SC, LOT# N201566030, IMPLANTED: 2009-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8709SC, LOT# N201566030, IMPLANTED: 2009-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS REPLACED BECAUSE OF THE BATTERY LIFE. PER THE REPORTER, THE BATTERY LIFE ¿CREPT UP ON THEM WITHOUT ANYONE KNOWING¿. ALSO PER THE REPORTER, DURING THE PUMP REPLACEMENT THEY DID NOT PLAN ON REPLACING THE CATHETER; HOWEVER, THEY SAW THAT THE CATHETER WAS CLOGGED. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS NOT SPECIFIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT PUMP ERI (ELECTIVE REPLACEMENT INTERVAL) ON (B)(6) 2013, IT WAS NOTED ¿NORMAL WITH HIGH DAILY OUTPUT OF THE PUMP.¿ THERE WERE NO SYMPTOMS REPORTED. CATHETER NOTED TO BE OBSTRUCTED DURING REPLACEMENT OF THE PUMP ON (B)(6) 2013. VISIT NOTES FROM (B)(6) 2013 REPORTED THAT THE INCISIONS WERE WELL-HEALED. THE PATIENT COULD RETURN BACK TO NORMAL ACTIVITY. IT WAS NOT REPORTED WHAT MEDICATION(S) WERE INFUSED BY THE SYSTEM AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457057 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention