MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number NEU_INS_STIMULATOR

Device Problems Electromagnetic Interference (1194); Overheating of Device (1437); Stretched (1601); Ambient Noise Problem (2877); Insufficient Information (3190)

Patient Problems Burn(s) (1757); Pain (1994); Burning Sensation (2146); Discomfort (2330); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.Caller asked to receive information regarding the use of diathermy on patient's that have spinal cord stimulation (scs) implants.Caller indicated that an event happened with a patient where they were burned at the location of the leads due to therapeutic ultrasound, 3 yrs after scs system implant.Reason for therapeutic ultrasound was to alleviate some pain pt was having.Patient (pt) informed person delivering the therapeutic ultrasound but that person indicated that wouldn't happen and therefore the pt was burned.Technical services (ts) reviewed diathermy information and provided patient programmer manual to show information regarding diathermy.Caller mentioned trial stim worked well but when ins and leads implanted that didn't seem to work well for pt for which she still had pain.At some point, everything was removed and except a "plug cover" and hcp just pulled the leads which stretched longer than the original lead.

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.

Manufacturer Narrative

Continuation of d10: product id: neu_unknown_lead, serial# (b)(6), implanted: (b)(6) 1999, explanted: (b)(6) 2008, product type: lead.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

The patient's representative (pt-rep) was contacted for additional information.Pt-rep did not remember dates.Pt-rep reported after the 4 day trial ended they took the lead out and put 2 leads in.Patient (pt) had the device off and was admitted to the hospital for pain.The ins was not taking care of the pain and pt wanted to find an alternative solution.Pt was hospitalized for a couple days.While in the hospital, pt had an ultrasound done and pt stated that it burned at the leads.Pt-rep stated that the hospital didn¿t notate that patient had any treatments done.Pt finally had the lead and ins removed.Pt-rep said the lead looked like part of it was missing and was stretched out.Pt-rep reported the healthcare provider (hcp) took it out, and the hcp seemed upset, and he did not get everything out.A different hcp was seen and the plug cover was taken out.Pt-rep said the plug cover was starting to build a lump over it and it was putting pressure on the nerve which is why pt wanted to have it removed.There was no rep present at the removal surgeries.The hcp they see suggested pt to get an ins.Pt-rep stated the hcp was unaware of the issues that can occur with the lead/ins so they explained to the hcp what can occur.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15288105
• MDR Text Key: 298562760
• Report Number: 2182207-2022-01636
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2023
• 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 Sex: Female