BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 959260 · Received December 5, 2007

    Report

    Report Number
    2182207-2007-04247
    Event Type
    Injury
    Date Received
    December 5, 2007
    Report Date
    October 17, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL REFERENCE: NOVAK, ET AL. "TWO CASES OF ISCHEMIA ASSOCIATED WITH SUBTHALAMIC NUCLEUS STIMULATOR IMPLANTATION FOR ADVANCED PARKINSON'S DISEASE". MOVEMENT DISORDERS, 2006, 21:1477-1483. DUE TO THE LIMITATIONS OF THE DATA, THE REPORTABLE EVENTS ARE BEING SUBMITTED BY COMPLICATION TYPE. THE EXACT RELATIONSHIP BETWEEN EACH PATIENT, THE DEVICES USED AND THE COMPLICATIONS EXPERIENCED WAS NOT PROVIDED. IT IS POSSIBLE THAT EACH PATIENT MAY HAVE EXPERIENCED MORE THAN ONE COMPLICATION. [SEE SCANNED PAGES.]

    Description of Event or Problem · 1

    JOURNAL REFERENCE: NOVAK, ET AL. "TWO CASES OF ISCHEMIA ASSOCIATED WITH SUBTHALAMIC NUCLUEUS STIMULATOR IMPLANTATION FOR ADVANCED PARKINSON'S DISEASE". MOVEMENT DISORDERS, 2006, 21:1477-1483. THE ARTICLE DESCRIBES TWO CASE STUDIES THAT INVOLVE ISCHEMIA ASSOCIATED WITH THE IMPLANT OF SUBTHALAMIC NUCLEUS STIMULATORS IN ADDITION, OTHER COMPLICATIONS FROM A SERIES OF PATIENTS TREATED WITH DBS FOR SYMPTOMS RELATED TO ADVANCED STAGE PD OVER THE LAST 5.5 YEARS ARE ALSO PRESENTED. REPORTABLE EVENTS: THREE PATIENTS EXPERIENCED INFECTIONS. NO TREATMENT OR OUTCOME INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention LEAD EXTENSION (N=2)| DBS LEAD MODEL 3389 (N=2)