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Model Number 9733858
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Hemorrhage, Cerebral (1889)
Event Date 01/21/2019
Event Type  Death  
Manufacturer Narrative
Patient information is provided. The dates the patient died are unavailable. Event date is approximated as it was reported to have occurred between (b)(6) 2009 and (b)(6) 2017. See mdr 1723170-2019-02729 for the report on the adverse events. Device lot number, or serial number, unavailable. The device was not returned, so no analysis was conducted. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. If information is provided in the future, a supplemental report will be issued. (b)(4).
Event Description
Citation: sobstyl, m. , aleksandrowicz, m. , zabek, m. , <(>&<)> pasterski, t. (2019). Hemorrhagic complications seen on immediate intraprocedural stereotactic computed tomography imaging during deep brain stimulation implantation. Journal of the neurological sciences, 400, 97-103. Doi:10. 1016/j. Jns. 2019. 01. 033 background: we present our operative experience of patients with movement disorders who developed intracerebral hemorrhage (ich), which was identified on intraprocedural stereotactic computed tomography (ct) imaging performed immediately after deep brain stimulation (dbs) lead placement and prior to the implantation of further components of the dbs hardware. Methods: patients who underwent dbs lead implantation from january 2009 through december 2017 were included in the present study. Most of the surgeries were performed in a staged fashion. All patients were operated using identical surgical and intraprocedural imaging techniques, and no microelectrode recordings were done. Leksell stereotactic g frame and neuronavigation software was utilized for all surgeries. Intraprocedural stereotactic ct was performed to confirm the precise position of the implanted dbs lead and to rule out any hemorrhagic complications. Results: overall, 222 patients underwent 322 dbs lead implantations during 316 stereotactic procedures. Six patients exhibited early ich recognized on intraprocedural stereotactic ct performed immediately after dbs lead placement; in addition, two patients developed delayed ich due to large venous infarction. Four patients with ich were asymptomatic. The ich rate was 2. 5% per electrode and 3. 6% per patient; the permanent deficit rate was 1. 2% per electrode and 1. 8% per patient. The death rate due to ich in our cohort was 0. 6% per electrode and 0. 9% per patient. Conclusions: intraprocedural stereotactic ct can not only visualize the implanted dbs lead in the stereotactic space but also rule out early ich. Identified predisposing factors for development of ich include patient's age, hypertension, and previous antiplatelet therapy. Careful planning of stereotactic trajectories plays a paramount role in reducing the rate of ich in dbs surgery. Adverse events 8 patients had intracranial hemorrhages (4 asymptomatic and 4 were symptomatic). (b)(6) year old female patient with hypertension, antiplated medication and essential tremor died 2 months after a dbs lead placement due to heart insufficiency. (b)(6) year old male patient with hypertension, antiplated medication and advanced parkinson's disease died 5 months after a dbs ead placement due to aspiration pneumonia. There was no alleged malfunction of the navigation device.
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Manufacturer (Section D)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
MDR Report Key8648021
MDR Text Key146325039
Report Number1723170-2019-02731
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 05/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9733858
Device Catalogue Number9733858
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/28/2019 Patient Sequence Number: 1