BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2181289 · Received July 21, 2011

    Report

    Report Number
    3007566237-2011-05636
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    September 22, 2005
    Report Date
    June 30, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z# 1151-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPERIENCING AN ELECTRICAL SHOCK SENSATION FROM THE PUMP, WHICH WAS FELT FROM THE PUMP LOCATION AND WENT TO HIS HEART. THE PT REPORTED THAT THIS SENSATION OCCURRED ALMOST CONTINUOUSLY AND WOULD BE MORE FREQUENT WHEN LEANING FORWARD. THE ISSUES BEGAN WHEN A GRANULOMA HAD BEEN FOUND IN (B)(6) 2011. IT WAS LATER REPORTED THE PT WAS DOING FINE. THE EVENT WAS NOT RELATED TO THE PUMP. THE PUMP WAS SCHEDULED TO BE REPLACED. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS ALSO STATED THAT "EVER SINCE HE HAD THE GRANULOMA, AND THEY SPLICED THE CATHETER AND HAD TO STRETCH IT TO GET IT BACK IN WHERE HE NEEDED IT, PATIENT HAD BEEN HAVING SENSATIONS. PATIENT HAD HAD THE GRANULOMA SINCE (B)(6) 2011. THE CATHETER WAS REPLACED (B)(6) 2011.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R CATHETER: MODEL 8709, LOT# J12531R01| EXPLANTED:| IMPLANTED: