BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 959255 · Received December 5, 2007

    Report

    Report Number
    2182207-2007-04248
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    JOURNAL REFERENCE: NOVAK, ET AL. "TWO CASES OF ISCHEMIA ASSOCIATED WITH SUBTHALAMIC NUCLEUS STIMULATOR IMPLANTATION FOR ADVANCED PARKINSONS'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 41 PATIENTS TREATED WITH DBS FOR SYMPTOMS RELATED TO ADVANCED STAGE PD OVER THE LAST 5.5 YEARS ARE ALSO PRESENTED. REPORTABLE EVENTS: TWO PATIENT (SOLETRA 7426 N=2) HAD DEVICE (UNSPECIFIED) FAILURES. 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 Other DBS LEAD MODEL 3389 (N=2)| LEAD EXTENSIONS (N=2)| IPG SOLETRA 7426 (N=1)