BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 959257 · Received December 5, 2007

    Report

    Report Number
    2182207-2007-04244
    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

    LABEL NA. JOURNAL REFERENCE: NOVAK, ET AL. "CASES OF ISCHEMIA ASSOCIATED WITH SUBTHALAMIC NUCLEUS STIMULATOR IMPLANTATION FOR ADVANCED PARKINSON'S DISEASE." MOVEMENT DISORDERS, 2006, 21:1477-1483.

    Description of Event or Problem · 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. THE ARTICLE DESCRIBES CASE STUDIES THAT INVOLVE ISCHEMIA ASSOCIATED WITH THE SUBTHALAMIC NUCLEUS STIMULATOR IMPLANTATION. IN ADDITION, OTHER COMPLICATIONS FROM 5.5 YRS OF DBS IMPLANT EXPERIENCE ARE ALSO PRESENTED. REPORTABLE EVENT: A MALE PT WITH TREMOR PREDOMINANT IDIOPATHIC PD ELECTED TO RECEIVE A STAGE BILATERAL STN DBS IMPLANT. TWO MONTHS FOLLOWING THE SUCCESSFUL IMPLANT OF THE LEFT BRAIN LEAD, THE RIGHT SIDE LEAD PLACEMENT SURGERY WAS UNDERTAKEN, MAPPING WITH A MICROELECTRODE WAS DIFFICULT (7 TRACKS) AND DESPITE AN UNEXPLAINED ABSENCE OF STN ACTIVITY, THE PERMANENT ELECTRODE (MODEL 3389) WAS IMPLANTED IN TRACK ONE. NO ADVERSE PT SYMPTOMS WERE NOTED DURING THE PROCEDURE. NEXT DAY MRI SHOWED EDEMA AND/OR ISCHEMIA (NONHEMORRHAGIC LESIONS DESCRIBED AS ISCHEMIC INFARCT). PT WAS DISCHARGED TO HOME. IN 3-6 DAYS PT REPORTED CONFUSION AND SHORT TERM MEMORY LOSS. ELECTROENCEPHALOGRAM AT 3 MONTHS POST SURGERY WAS MORE PRONOUNCED AND FOCAL TO THE RIGHT SIDE. SOME BILATERAL EPILEPTIFORM ACTIVITY DURING SLEEP WAS ALSO NOTED. PT WAS TREATED WITH ANTICONVULSANTS AND CONFUSION SYMPTOMS IMPROVED WITH SOME PERSISTENT SHORT-TERM MEMORY PROBLEMS. TREMOR WAS EFFECTIVELY CONTROLLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION 3389 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R MICROELECTRODE-RECORDING (MFG FHC)| DBS LEAD MODEL 3389 (N=1)| IPG SOLETRA 7426 (N=2)| LEAD EXTENSIONS (N=2)