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

Model Number 97715

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Electric Shock (2554); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

Event Date 12/03/2021

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).It was reported that the patient was implanted in (b)(6) 2021. pt thinks starting 2 weeks ago they started having a problem with their stomach and the pt had used 1 or 2 and felt it was very hard and it was not at 4 (ps (patient services) understood pt had the intensity at 4 but it was going down by 1 or 2 intensity on own).Pt noted their stomach was out of place as was not in right place and they thinks it was because of this treatment (ps understood the ins).Pt noted they thought of doing lower doses (ps understood lower intensity) but pt did not know if the issue for their stomach was with the stimulator or transmitter.Pt had to check their device several times and they have at 4 to 6 (ps was confused and clarification from pt was not provided).Pt noted that when they went to check the stimulator to see if the stimulator was higher it was not working and said to call the manufacturer.Pt noted its not working and they don't have treatment (ps understood treatment from their ins).Pt wanted to know why the intensity changes alone without them doing so.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

The patient stated that hey had an endoscopy and her stomach moved.The patient wanted to know if it was possible that her stomach moved due to the stimulation.The patient stated that after implant, she felt the stimulation very strong.After her second appointment with a manufacturer representative (rep), in which the rep adjusted stimulation, she started to feel that the stimulator was giving her like electric shocks in the stomach and she could feel how her stomach would contract and move.The patient stated that she felt these strong sensations with movement, like when she moved her arms upwards.The patient stated that ever since then, when she verifies her programmer, the stimulation has changed by itself.The patient stated that she hasn¿t seen the manufacturer representative (rep) again however she constantly sees her healthcare provider (hcp).The patient adjusts stimulation herself and since the strong sensations, she has kept her stimulation under 2.0 volts.The patient said sometimes she has back pain and wants to increase stimulation but she is afraid of the strong electrical shocks happening again.The patient has an appointment on (b)(6) 2022 with the healthcare provider (hcp) and will notify the hcp about her stomach moving and will confirm if this was caused by the stimulator however the patient is convinced the root cause of the stomach moving is the stimulator.Patient implant date is (b)(6) 2021 and weight is 172 pounds.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: 13055775
• MDR Text Key: 282624209
• Report Number: 3004209178-2021-18889
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2021
• Date Device Manufactured: 01/12/2021
• 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 Age: 59 YR
• Patient Sex: Female
• Patient Weight: 78 KG