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

Model Number 97715

Device Problems Break (1069); Intermittent Continuity (1121); High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Application Program Problem (2880); Electromagnetic Compatibility Problem (2927); Impedance Problem (2950); Patient Device Interaction Problem (4001)

Patient Problem Electric Shock (2554)

Event Date 03/17/2022

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant medical products: product id 977a260, serial# (b)(4), implanted: (b)(6) 2021, product type: lead, ubd: 21-dec-2024, udi#: (b)(4).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

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain indications.It was reported that the patient (pt) went skydiving which caused their lead to break and went in and had unit adjusted so that the unit would work but somehow broke again.Pt stated the left lead is broke and trying to run stimulator off right lead to help.Pt stated they keep seeing cannot provide desired density.Pt stated they went skydiving march 17 and the rep reprogrammed back a week later and then two weeks ago driving home and stimulator started turning off and on and pt felt this so turned off stim and went to see rep again and rep said entire left lead broken except for tiny spot.Pt stated they are not doing surgery yet as they are trying to bypass surgery so currently just running stim off right lead.Pt stated the hcp is having the pt wait one month and re-evaluate.Pt stated may 31 is when the stim would turn on and off itself when pt would tilt head one way or another and feel the stim turning itself.Pt mentioned hard to explain, felt shocking sensation.Pt states one time in car shocked legs and seemed like she increasing high in legs.Pt stated stim was working until second incident which was may 31.Pt stated randomly doesn't find ins now.The patient was redirected to their healthcare provider to further address the issue.Pt has been in touch with the hcp.On (b)(6) 2022 a rep reported that the pt reached out them stating they are planning an appointment with their hcp, the rep will see about reprogramming the pt.A rep met with the pt on (b)(6) 2022 and attempted to reprogram the lead and was unsuccessful at achieving left sided stimulation.Rep performed an impedance check and all the contacts seem to be in good condition except for contacts 3 and 6.However during reprogramming the rep was reading oor with every configuration attempted at less than 2ma.The patient said they would be reaching out to their hcp for a consult on a revision of the stimulator.

Manufacturer Narrative

Continuation of d10: product id 977a260 lot# serial# (b)(6) implanted: (b)(6) product type lead product id 977a260 lot# va2c93g012 serial# (b)(6) 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

Caller stated leads had high impedances - specifically, contacts 3 and 6 were over 40k ohms.Revision was performed today in which perc leads were removed and surgical lead was implanted.In the or, while patient was awake, they confirmed they were getting good stim.Caller checked impedances intra-op and all were within normal range.Caller will be returning leads.Return paperwork stated lead short circuit.

Manufacturer Narrative

Pli 20: analysis update: the returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that#0 - 3, 6 and 7 conductors were broken, 18.0 cm from the distal end.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

Patient reported that the cause was their lead would not connect to rep's connector and it was sharing nothing was broken but it was the first time patient saw the rep.They tried to turn off at just patient's right lead to help but it wasn't helping.They ended up replacing the stimulator with a paddle.The issue was resolved.

• 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: 14847291
• MDR Text Key: 303061442
• Report Number: 3004209178-2022-08234
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2022
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2022
• Date Device Manufactured: 04/16/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 73 KG