BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1248104 · Received December 1, 2008

    Report

    Report Number
    3004209178-2008-07848
    Event Type
    Injury
    Date Received
    December 1, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 3, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    MYH
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON 11/06/2008 THE EXPLANTED DEVICES HAVE BEEN RETURNED TO THE MFR FOR ANALYSIS, WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE DEEP BRAIN STIMULATOR, LEAD AND EXTENSION WERE EXPLANTED DUE TO INFECTION (CAUSATIVE ORGANISM UNK). PT SYMPTOMS INCLUDED REDNESS AND SWELLING AT THE DEVICE IMPLANT SITE OF THE CHEST, NECK AND HEAD. THE PT OUTCOME WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MYH MEDTRONIC PUERTO RICO OPERATIONS CO 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention IMPLANTABLE NEURO STIMULATOR: MODEL 7426| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482| PROGRAMMER: MODEL 7438| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7438| EXPLANTED| EXPLANTED:| LEAD: MODEL 3387S| EXPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3387S| IMPLANTED:| LOT# NFW140170H| IMPLANTED: