BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1871034 · Received October 12, 2010

    Report

    Report Number
    9614453-2010-07838
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 14, 2010
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    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). FINAL DEVICE ANALYSIS REVEALS NO ANOMALY FOUND AND IPG IS FUNCTIONALLY OK.

    Description of Event or Problem · 1

    IT WAS REPORTED IMPEDANCES IN ALL UNIPOLAR AND BIPOLAR ELECTRODES INCREASED TO GREATER THAN 2000 OHMS FOR PT'S IMPLANTABLE PULSE GENERATOR (IPG) TWO MONTHS POST-IMPLANT. ELECTROMAGNETIC INTERFERENCE WAS SUSPECTED AT THE TIME AND THE PT HAD REGULAR CHECKS TO ADJUST PARAMETERS. IT WAS NOTED THAT THE REGULAR ADJUSTMENTS DID NOT IMPROVE PT'S SYMPTOMS. THE PT HAD THE ENTIRE SYSTEM REPLACED AND THE PT'S SYMPTOMS DECREASED. REFER TO MFR REPORT # 9614453-2010-07839.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC EUROPE SARL 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention EXTENSION: MODEL 7482, LOT # NHU182345V| EXPLANTED:| LEAD: MODEL 3389, LOT# V275097| IMPLANTED:| IMPLANTED:| EXPLANTED: