BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2210325 · Received August 9, 2011

    Report

    Report Number
    3004209178-2011-06167
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEEDED AN MRI DUE TO MIGRAINES. STIMULATION COVERAGE TO THE PATIENT'S BACK WAS INADEQUATE AND THE NEUROSTIMULATOR WAS "DUE FOR REPLACEMENT." DUE TO THE NEED FOR AN MRI AND NEUROSTIMULATOR REPLACEMENT, THE NEUROSTIMULATION SYSTEM WAS EXPLANTED AND WAS GOING TO BE REPLACED AT ANOTHER TIME. THE PATIENT INCURRED NO INJURY AND RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-51, LOT # XR0082554N| IMPLANTED:| EXTENSION: MODEL 7495-51, LOT # XR0082555N| IMPLANTED:| LEAD: MODEL 3998, LOT # L82738| IMPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL BOOT, LOT # UNKNOWN| STIM ACCESSORY: MODEL BOOT, LOT # UNKNOWN| IMPLANTED: