MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97714

Device Problem Electromagnetic Compatibility Problem (2927)

Patient Problems Inflammation (1932); Pain (1994); Discomfort (2330); Insufficient Information (4580)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that patient was put on a cpap machine less than a week ago and at first the pressure was fine, but 2 days ago they doubled the cpap pressure and that affected a nerve in her back, really flared it up which is causing pt excruciating pain.Pt asked if cpap can affect her ins, which she knows it has.Patient services (pss) reviewed no testing on cpap and ins.Pt said when they doubled the pressure it forced air up her nose, pushing her nose and neck back a little bit.She said she has a pinch nerve in l4, l5 (which is why she has the stimulator) so the doubled pressure affected her neck, went down to the base of her back, and went down her leg where the pain normally goes.She also mentioned she couldn't move her toes and her hands started curling up.Pt said they tried lowering the pressure on the machine, but that didn't work, so they are going to try again today to see if the pressure would lower or not.She said the cpap doc/nurse told her not to use "it" (unclear whether cpap or ins) for a night or two, blaming it on the stimulator, but pt said her nerve is so inflamed right now that she doesn't know if it will calm down in a night or two.She said she tried explaining to the cpap hcp how cpap was affecting her, but they said that is the pt's problem and that they didn't deal with pain.Pt also mentioned ins is working fine, and it is the only think allowing her to walk, that it is the best thing that ever happened.Pss redirected to hcps to discuss concerns.

Event Description

Patient reported she will be resolving this issue by not be turning up the pressure because this bothers her too much.Patient states she has an appt with her hcp.

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

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.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

Patient reported that they had interference of the cpap machine has been resolved.Hcp told patient that their numbers dropped ("stopped breathing") to 18 from 20.And they are at the results of the pressure between 6 to 10, which was giving the patient those results, so they are not going to increase the pressure that gave them pain in patient's back.Patient reported that it was resolved.The doctors plans is to keep the pressure exactly where it is from 6 to 10 and there's been no issues since those two nights that the patient had.Pt states that a note was sent to her family hcp as well regarding this situation.Pt states that she loves the scs, and wouldn't be able to walk without her implant.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10993550
• MDR Text Key: 221286270
• Report Number: 3004209178-2020-21703
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 80