MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT

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.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12625730
• MDR Text Key: 276208648
• Report Number: 1723170-2021-02499
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/13/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR