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Model Number UNK_NAV_SYS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); High Blood Pressure/ Hypertension (1908); Hydrocephalus (3272)
Event Date 08/03/2021
Event Type  Injury  
Manufacturer Narrative
Patient age is the mean value of patients in the study. Patient gender is the majority value of patients in the study. Patient weight not available from the site. Event date is the online publishing date of the literature article. Device lot number, or serial number, unavailable. 510(k) is dependent upon the device model number and is therefore, unavailable. No parts have been received by the manufacturer for evaluation. Device manufacture date is dependent on the device lot/serial number, therefore is unavailable. If information is provided in the future, a supplemental report will be issued.
Event Description
Runge, j. , ascencao, l. C. , blahak, c. , kinfe, t. M. , schrader, c. , wolf, m. E. , saryyeva, a. , krauss, j. K. Deep brain stimulation in patients on chronic antiplatelet or anticoagulation treatment. Acta neurochirurgica 2021. Https://doi. Org/10. 1007/s00701-021-04931 background: in the aging society, many patients with movement disorders, pain syndromes, or psychiatric disorders who are candidates for deep brain stimulation (dbs) surgery sufer also from cardiovascular co-morbidities that require chronic antiplatelet or anticoagulation treatment. Because of a presumed increased risk of intracranial hemorrhage during or after surgery and limited knowledge about perioperative management, chronic antiplatelet or anticoagulation treatment often has been considered a relative contraindication for dbs. Here, we evaluate whether or not there is an increased risk for intracranial hemorrhage or thromboembolic complications in patients on chronic treatment (paused for surgery or bridged with subcutaneous heparin) as compared to those without. Methods: out of a series of 465 patients undergoing functional stereotactic neurosurgery, 34 patients were identified who were on chronic treatment before and after receiving dbs. In patients with antiplatelet treatment, medication was stopped in the perioperative period. In patients with vitamin k antagonists or novel oral anticoagulants (noacs), heparin was used for bridging. All patients had postoperative stereotactic ct scans, and were followed up for 1 year after surgery. Results: in patients on chronic antiplatelet or anticoagulation treatment, intracranial hemorrhage occurred in 2/34 (5. 9%) dbs surgeries, whereas the rate of intracranial hemorrhage was 15/431 (3. 5%) in those without, which was statistically not significant. Implantable pulse generator pocket hematomas were seen in 2/34 (5. 9%) surgeries in patients on chronic treatment and in 4/426 (0. 9%) without. There were only 2 instances of thromboembolic complications which both occurred in patients without chronic treatment. There were no hemorrhagic complications during follow-up for 1 year. Conclusions: dbs surgery in patients on chronic antiplatelet or anticoagulation treatment is feasible. Also, there was no increased risk of hemorrhage in the first year of follow-up after dbs surgery. Appropriate patient selection and standardized perioperative management are necessary to reduce the risk of intracranial hemorrhage and thromboembolic complications. Reportable events: there was one patient who suffered from mild intraoperative air embolism with coughing, but without dyspnea or hemodynamic instability. A (b)(6) year-old man had an intraventricular hemorrhage associated with a transventricular electrode in the postoperative ct. After four asymptomatic days, his condition worsened due to hydrocephalus, requiring an external ventricular drainage for 5 days. A (b)(6) year-old woman had a small, asymptomatic intracerebral bleeding along the electrode trajectory in the postoperative ct scan. There were no longterm consequences. 16 patients had arterial hypertension. 2 patients had ipg pocket hematomas see literature article attached.
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
MDR Report Key12625730
MDR Text Key276208648
Report Number1723170-2021-02499
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeGM
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 10/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK_NAV_SYS
Device Catalogue NumberUNK_NAV_SYS
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 Received10/01/2021
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: 10/13/2021 Patient Sequence Number: 1