MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); High impedance (1291); Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Increased Sensitivity (2065); Therapeutic Response, Decreased (2271); Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

Literature citation: choi sc, chae js, kim yj, chon jy, moon hs.Lead fracture in peripheral nerve stimulation for brachial plexopathy: a case report.Korean journal of anesthesiology.2018.Doi: 10.4097/kja.D.17.00023.It was not possible to ascertain specific device information from the article or to match the reported events with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Device used for off label indication.The indication the device was used for was peripheral nerve stimulation.Concomitant medical products: product id: neu_unknown_lead, lot # unknown, product type: lead; product id: neu_unknown_lead, lot # unknown, product type: lead.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown, ubd: asku, udi#: asku.If information is provided in the future, a supplemental report will be issued.

Event Description

Literature abstract: peripheral nerve stimulation (pns) is a useful treatment for chronic pain, but it can cause damage depending on its application site.In the article, the authors described the case of a (b)(6) man who underwent pns for brachial plexopathy in 2015.One lead was implanted on the left medial cord to stimulate the medial antebrachial cutaneous nerve, and the other was implanted on the radial nerve to stimulate the posterior antebrachial cutaneous nerve.Both leads were inserted near the shoulder joint but did not cross it.Before pns, the patient did not move his shoulder and elbow because of severe pain, but the treatment greatly alleviated this pain.Twenty months after the operation, both leads were fractured, and the severe pain returned.Repetitive motion near the joint was closely related to the lead fractures.In conclusion, clinicians should carefully consider the insertion sites of pns leads in order to avoid lead fractures.Reported events: in 2015, a (b)(6) man underwent peripheral nerve stimulation (pns) for brachial plexopathy that resulted from a video-assisted thoracoscopic surgery (vats) for a superior mediastinal schwannoma that was performed eight years earlier.After the vats, he reported pain in his medial and posterior forearm, especially in areas innervated by the posterior and medial antebrachial cutaneous nerves.He rated his pain intensity as 8¿9 on a 10-point numeric rating scale (nrs) in which 0 indicated no pain and 10 indicated the worst pain imaginable.Electromyography revealed left brachial plexopathy that mainly involved the medial and posterior cords.The patient¿s pain was intractable to various conservative pharmacological and non-pharmacological treatments, so he had received spinal cord stimulation (scs) for three years.However, his condition became resistant to this treatment, so it was switched to ultrasound-based pns that was performed with percutaneous electrical leads.One lead was implanted on the left medial cord via an infraclavicular approach to stimulate the medial antebrachial cutaneous nerve, and the other was implanted on the radial nerve via an axillary approach to stimulate the posterior antebrachial cutaneous nerve.Both leads were inserted near the shoulder joint, but did not cross it.Before pns, the patient did not move his shoulder and elbow because of severe pain, but the treatment greatly alleviated this pain.After the pns, his nrs-reported pain decreased from 8¿9 to 1¿2, and he required no analgesics.The pns provided effective therapy for approximately 20 months, but then the patient¿s pain returned at an nrs-reported level of 7¿8.He reported a frequent electric shock-like sensation at the implantable pulse generator¿s insertion site, and a physical examination revealed hyperalgesia and mechanical allodynia on his medial and posterior forearm.It was noted that fractures of both electrical leads was confirmed with a physician programmer; abnormally high electrode impedances (> 10,000 ohms) were measured.It was stated that repetitive motion near the shoulder joint was closely related to the lead fractures and that ¿the implanted leads moved with the shoulder¿s increased motion range, which may have caused the lead fractures.¿ the fractured leads were removed, and a new lead was inserted onto the medial cord with ultrasound guidance.The patient was placed in a supine position with his arm abducted.After obtaining a short-axis view of the axillary artery and vein, a tuohy needle was placed in-plane between the axillary artery and the medial cord and then 10 ml of normal saline was injected to provide space for the lead.The tuohy needle¿s bevel was turned toward the trunk and gently inserted until resistance was detected.The tuohy needle was removed and the lead¿s position adjusted with repeated electrical stimulation because the lead was obscured in the ultrasound-images.It was found that only one new lead was required to adequately cover all painful areas; the lead was inserted at a new site further from the joint.After this insertion, the patient¿s nrs-reported pain decreased from 8¿9 to 1¿2.There were no further complications reported or anticipated.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the article¿s author of correspondence confirmed the devices involved in the article were manuf actured by this manufacturer.No further event information was provided.No further complications were reported or anticipated.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 7902557
• MDR Text Key: 121498414
• Report Number: 3007566237-2018-02852
• Device Sequence Number: 1
• Product Code: GZF
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention