BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1983049 · Received February 4, 2011

    Report

    Report Number
    3004209178-2011-00883
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    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 F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE DEEP BRAIN STIMULATOR, EXTENSION, AND LEAD WERE REMOVED DUE TO DEHISCENCE, AND INFECTIOUS COMPLICATION. THE DEVICE WAS NOT REPLACED. THERE WAS NO PT INJURY ASSOCIATED WITH THE EVENT. PLEASE REFERENCE MF REPORT # 3004209178-2011-00412. THIS MFR WAS ORIGINALLY AND INCORRECTLY FILED UNDER THE INCORRECT DEVICE SYSTEM WHICH ARE CONCOMITANT PRODUCTS. ANY ADD'L INFO WILL BE FILED IN THIS NEW MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention EXPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL BURRHOLE CAP, LOT# UNK| EXTENSION: MODEL 7482A51, LOT# NHU199015V| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V264301| EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V253613| EXPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU199012V| IMPLANTED:| MODEL 7426, LOT# NFW155706H| IMPLANTED:| EXPLANTED: