BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2855068 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11092
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    November 7, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3998, LOT# J0357391V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL TRYING TO CONTACT A COMPANY REPRESENTATIVE SO THAT THEY COULD FIND OUT WHY THEIR UNIT WAS 'NOT WORKING AT ALL.' IT WAS STATED THAT THE PATIENT'S PHYSICIAN WAS NOT LOCAL AND THAT THEY NEEDED TO SEE A REPRESENTATIVE 'ONE ON ONE.' FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO TURN HER DEVICE BACK ON AFTER A MAGNETIC RESONANCE IMAGING (MRI) OF THE HEAD. IT WAS STATED THAT THE PATIENT WAS UNABLE TO MAKE AN ADJUSTMENT WITH OR WITHOUT THE ANTENNA ATTACHED. THE REPORTER STATED THAT THE DEVICE WAS TURNED OFF THE PREVIOUS NIGHT AND CONFIRMED THIS WITH NO LONGER BEING ABLE TO FEEL THE TINGLING SENSATION. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE DATE OF THIS REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1