MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cognitive Changes (2551)

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

These events were reported in literature article: strauss, ido; berger, assaf; arad, michal; hochberg, uri."o-arm-guided percutaneous radiofrequency cordotomy." sterotactic and functional neurosurgery, 95, 2017: 409-416.Patient information was unavailable from the site.The age provided was the mean of the all the patients involved in the literature.The gender provided is the gender of the majority of the patients.No parts have been received by the manufacturer for evaluation.[(b)(4)].Part not returned.

Event Description

The following events were reported via literature: background: pain is often one of the most debilitating symptoms in patients with advanced oncological disease.Patients with localized pain due to malignancy refractory to medical treatment can benefit from selective percutaneous cordotomy that disconnects the ascending pain fibers in the spinothalamic tract.Objectives: over the past year, we have been performing percutaneous radiofrequency cordotomy with the use of the o-arm intraoperative imaging system that allows both 2d fluoroscopy and 3d reconstructed computerized tomography imaging.We present our experience using this technique, focusing on technical nuances and complications.Methods: a retrospective analysis was conducted of all patients who underwent percutaneous cordotomy between march 2016 and march 2017.Results: nineteen patients underwent percutaneous cordotomy procedures.Two patients developed intraoperative delirium and were unable to tolerate the procedure.In 16 out of 17 completed procedures, we achieved excellent immediate pain relief (94%).At 1 month after operation, 15 of the 17 (88%) patients were pain free, and at 3 months 5 out of 5 patients available for follow-up were still free of their original pain.Mirror pain developed in 6 of the 17 patients (35%), but was mild in 4 of these cases and controlled with medications.We experienced 1 serious complication (6%) of ipsilateral hemiparesis.Conclusion: percutaneous cordotomy using the o arm is safe and effective in the treatment of intractable oncological pain.Reported events: (b)(6) year old male with intra-operative delirium after mild sedation with propofol and remifentanil for pin placement.Procedure was aborted.A (b)(6) year old male with intra-operative delirium after mild sedation with propofol and remifentanil for pin placement.Procedure was aborted.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: pa chia vue ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7682064
• MDR Text Key: 113786527
• Report Number: 1723170-2018-02963
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169505742
• UDI-Public: 00643169505742
• Combination Product (y/n): N
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/12/2018

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: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2015
• 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: 65 YR