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

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); Electromagnetic Interference (1194)

Patient Problems Abdominal Pain (1685); Pain (1994); Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: neu_unknown_lead, serial#: unknown, product type: lead.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a other regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that on (b)(6) 2019 the patient was admitted to the hospital with complaints of ongoing lumbar back pain around her spinal stimulation and abdominal pain as well as a burning pain radiating down her bilateral legs from the site of her stimulator.The patient was examined on (b)(6) 2019 by the healthcare provider (hcp) and requested a manufacturer's representative (rep) to discuss the spinal stimulator before making a decision.A rep evaluated the patient on (b)(6) 2019 and found the inss life span was to end in (b)(6) 2020.The rep also told the patient it was safe for her to undergo an mri even though the stimulator was not mri compatible.It was decided on (b)(6) 2019 to change the ins out to an mri compatible battery which the hcp believed would allow the patient to safely undergo an mri.The patient underwent a revision and replacement of the ins on (b)(6) 2019. the hcp replaced the ins but not the leads.The patient later underwent an mri on (b)(6) 2019 of the lumbar spine without contrast during which the patient experienced burning pain in her neck and back as well as at the peripheral lead sites.The patient was informed on (b)(6) 2019 that the hcp did not change the leads on the ins when the ins was replaced and the leads were not mri compatible.The hcp did not replace the leads at the time the ins was replaced because it was not his specialty.On (b)(6) 2020 the patient underwent surgery to have the entire system, ins and leads removed due to ongoing pain.After the surgery, the patient was informed that the leads were damaged, fractured, singed and one lead had snapped.

Manufacturer Narrative

Continuation of d10: product id neu_unknown_lead, serial# unknown, product type: lead.Additional information indicated this event has also been reported in mfg report 3004209178-2019-21377.Any additional information regarding the event will be documented in that report.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.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 11599127
• MDR Text Key: 243401281
• Report Number: 2182207-2021-00562
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/01/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 04/01/2021
• Supplement Dates FDA Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention