BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3052473 · Received April 11, 2013

    Report

    Report Number
    3007566237-2013-01211
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731 LOT# SERIAL# (B)(4), IMPLANTED: 2005-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: 2005-(B)(6), PRODUCT TYPE CATHETER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTH CARE PROVIDER HAD NOT SEEN THE PATIENT SINCE (B)(6) 2010. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS FLIPPING ALL THE WAY OVER COMPLETELY, BUT WAS STILL PROVIDING THE PATIENT PAIN RELIEF. THE PUMP WAS SUBSEQUENTLY REPLACED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155890 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention