MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI

Model Number 37601

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Adhesion(s) (1695); Chest Pain (1776); Dysphagia/ Odynophagia (1815); Fatigue (1849); Inflammation (1932); Muscular Rigidity (1968); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Tinnitus (2103); Dysphasia (2195); Neck Stiffness (2434); Ambulation Difficulties (2544); Weight Changes (2607); Skin Inflammation/ Irritation (4545); Decreased Appetite (4569); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: b35200, serial# (b)(4), implanted: (b)(6) 2021, product type: implantable neurosti mulator.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2018, the patient had a "formation of scar tissue" that caused them to have pain and stiffness.The patient did not provide the location of the scar tissue (due to the nature of the call, agent did not ask them for it).The patient indicated that these problems may have been caused by exercising after the ins was implanted, because they mentioned that they were never told that they could not exercise after the ins was implanted.On (b)(6) 2019, the patient stated that they had their first revision due to "tethering." the patient indicated that the "tethering" was the formation of the scar tissue.For the first revision, the patient stated they were told the surgeon was going to "move the generator and clean the wires." the patient then stated, "i'm not sure what they did, but they screwed me up." the patient explained that after the first revision, they lost 35 pounds due to weakness and lack of appetite.As a result of the weight loss, the patient stated that "everything got tight," and that the ins had sharp edges poking through their chest.The patient stated the stiffness and pain got worse after the first revision, and they also developed problems with balance.The patient stated that they suffered "pretty much through 2019" and ended up going to the university (b)(6) to have their second revision, which occurred on (b)(6) 2020.The patient stated that the reason for the second revision was to address all the problems caused by the first revision, which included the balance problem, increased pain, stiffness, and weight loss.After the second revision, the patient stated they still had pain, and then they developed dysarthria (trouble speaking) and had trouble swallowing.The patient stated that most of their problems were better after the second revision, but they still had chest and shoulder pain.The patient noted that they also developed a condition called scapular winging, diagnosed on (b)(6) 2020.The patient indicated that the scapular winging was a result of a surgical problem from the second revision.The patient stated that there was a discussion about having a couple of surgeries to correct the scapular winging.On (b)(6) 2021, however, the patient stated that all three of their surgeons agreed that the patient should have a third revision, which was when the percept pc replaced the activa pc.The patient stated a lot of their problems were resolved after the percept pc was implanted.However, the patient stated that they still suffer from pain, although not as bad.Regarding the percept pc, the patient stated, "the nice thing about percept is that it has no sharp edges poking through my chest." the patient mentioned that the percept pc was "activated" in (b)(6) 2021.The patient stated that they have been to a couple of pain centers to address their pain, and their psychologist advised the patient to consider a spinal cord stimulator (scs).The patient was redirected to their healthcare provider to further address the issue.

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 was received from the consumer reporting that they had initial surgery in (b)(6) 2018 with activation in (b)(6) 2018.Within weeks, they developed tightness in their chest and difficulty moving their head.Exercise was discouraged because they had "extensive wiring".They were sent for a second opinion where they were informed that physical therapy is crucial to avoid scar tissue formation.Movement of their head became increasingly difficult with persistent tension in their ribs.They had a chest x-ray which the doctor noted the formation of scar tissue at "extension loop".The patient stated the cause of the scar tissue formation and pain was because physical therapy was discouraged by the surgical team.After their revision in (b)(6) 2019, there was increased severity of their symptoms (gait, balance, dysarthria, dysphagia, pain, stiffness in ribs, neck, and chest).Their postprandial somnolence worsened and they had weight loss.They became semi-retired due to the difficulty tolerating the pain.A doctor identified the rib issue as "tethering" resulting in the patient having a second revision in (b)(6) 2020.At follow-up visits, the patient had intermittent pain when pressing on the ribs on both sides of the chest and was later diagnosed as neurodermatitis on (b)(6) 2020.Tinnitus started (b)(6) 2020 and is still present.(b)(6) 2020, they were diagnosed with left scapula winging due to spinal accessory nerve damage during the previous revision, which also resulted in atrophy of the trapezius muscle with inflammation of the scm muscle.They saw ent for voice therapy and swallowing test.They started wearing a shoulder brace for the winging and walked with a cane.A dbs revision was recommended because the problems were related to wiring in the chest, over clavicle, and in neck.The third revision occurred in (b)(6) 2021 with the replacement of activa pc to percept pc, with little improvement.There's no noticeable scar tissue after the most recent revision.There has been no new pain after the most recent revision and device replacement.The patient is present and has been for over 3 years.However, they are currently experiencing pain in their chest (intercostal) and neck, unilateral tinnitus, dysarthria, dysphagia, gait and balance issues, difficulty moving their head, neurodermatitis, and inflammation of scm muscle.They will start massage therapy and yoga soon.Treatment for the existing pain has included surgical revision, medication (hydrocodone, pregabalin, baclofen, and more), physical therapy, acupuncture, and more.

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 was received from the consumer reporting that they had initial surgery in (b)(6) and (b)(6) 2018 with activation in march.Within weeks, they developed tightness in their chest and difficulty moving their head.Exercise was discouraged because they had "extensive wiring".They were sent for a second opinion where they were informed that physical therapy is crucial to avoid scar tissue formation.Movement of their head became increasingly difficult with persistent tension in their ribs.They had a chest x-ray which the doctor noted the formation of scar tissue at "extension loop".The patient stated the cause of the scar tissue formation and pain was because physical therapy was discouraged by the surgical team.After their revision in (b)(6) 2019, there was increased severity of their symptoms (gait, balance, dysarthria, dysphagia, pain, stiffness in ribs, neck, and chest).Their postprandial somnolence worsened and they had weight loss.They became semi-retired due to the difficulty tolerating the pain.A doctor identified the rib issue as "tethering" resulting in the patient having a second revision in (b)(6) 2020.At follow-up visits, the patient had intermittent pain when pressing on the ribs on both sides of the chest and was later diagnosed as neurodermatitis on (b)(6) 2020.Tinnitus started (b)(6) 2020 and is still present.(b)(6) 2020, they were diagnosed with left scapula winging due to spinal accessory nerve damage during the previous revision, which also resulted in atrophy of the trapezius muscle with inflammation of the scm muscle.They saw ent for voice therapy and swallowing test.They started wearing a shoulder brace for the winging and walked with a cane.The third revision occurred in (b)(6) 2021 with the replacement of activa pc to percept pc, with little improvement.There's no noticeable scar tissue after the most recent revision.There has been no new pain after the most recent revision and device replacement.The patient is present and has been for over 3 years.However, they are currently experiencing pain in their chest (intercostal) and neck, unilateral tinnitus, dysarthria, dysphagia, gait and balance issues, difficulty moving their head, neurodermatitis, and inflammation of scm muscle.They will start massage therapy and yoga soon.Treatment for the existing pain has included surgical revision, medication (hydrocodone, pregabalin, baclofen, and more), physical therapy, acupuncture, and more.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12804442
• MDR Text Key: 284134737
• Report Number: 3004209178-2021-16929
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2021
• Date Device Manufactured: 11/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 84 KG