BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPG NEURO

    MDR report key: 1082604 · Received July 25, 2008

    Report

    Report Number
    2182207-2008-04420
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL MONTHS AFTER A STIMULATION SYSTEM WAS IMPLANTED, THE PT FELT THE STIMULATION FROM IPG HAD BEEN INTERMITTENT. THE HCP SUSPECTED A POSSIBLE LEAD FRACTURE HAD OCCURED AND DECIDED TO REPLACE THE LEAD. NO OTHER SYMPTOMS OR OUTCOME WERE REPORTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE. PLEASE SEE MFR. REPORT #2182207200804421.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPG NEURO GZB MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention LEAD MODEL 3387-33 LOT# V081263| IMPLANTED:| EXPLANTED: