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

Model Number 97715

Device Problems Data Problem (3196); Patient Device Interaction Problem (4001)

Patient Problem Paresthesia (4421)

Event Date 06/29/2022

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain indications.The reason for call was the pt reported changes in therapy settings/intensity when performing physical therapy (pt) exercises for about a month.Pt stated they had their shoulder replaced 9 weeks ago and is currently undergoing outpatient therapy.Pt said (during therapy exercises) whenever they have to raise their arms above their head or lay down on their back the neurostimulator (ins) gives them the little needles/tingling sensation only when performing pt.Pt wanted to know if they should shut the ins off or lower the charge to get them through the therapy.Pt confirmed they were not experiencing an actual shocking but rather pt was concern about things messing up by adjusting programmed settings/intensity.Patient services specialist (pss) reviewed to try turning ins off when doing exercises to provide comfort before attempting to adjust intensity.Ps reviewed turning ins off momentarily would not effect the ins battery.Pt mentioned having the ins reprogrammed prior to shoulder surgery.Pt said the therapy wasn't doing well for them (prior to reprogramming) so it was "upped".The patient was redirected to their healthcare provider to further address the issue if turning ins off during pt did not provided comfort.Pss advised pt they could also discussed adjusting therapy settings (for when in pt) with medtronic representative.

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.

• 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: 15147576
• MDR Text Key: 304773528
• Report Number: 3004209178-2022-09761
• 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
• Report Date: 08/02/2022

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 Expiration Date: 12/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2022
• Initial Date FDA Received: 08/02/2022
• Date Device Manufactured: 12/30/2020
• 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: 76 YR
• Patient Sex: Male