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

Model Number 97715

Device Problems Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); High impedance (1291); Failure to Interrogate (1332); Unintended Collision (1429); No Device Output (1435); Device Difficult to Program or Calibrate (1496); Battery Problem (2885); Communication or Transmission Problem (2896); Loss of Data (2903); Device Contamination with Chemical or Other Material (2944); Impedance Problem (2950); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Inadequate Pain Relief (2388); Insufficient Information (4580)

Event Date 07/01/2019

Event Type  Injury  

Event Description

Information was received from multiple sources (patient, manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient reported a fall a couple of years ago and has quite a hard lump on her back.She reports that it was after this fall that the impedance issues began.As of 2019-jul-22, contact 7 was out of range.It was noted that in 2022, the patient had three out of range impedances.They programmed around the high impedances while the patient waited for a surgery date.The ins was switching off, this was seen whilst interrogating the system in clinic.They sent for an x-ray and had exploration at the ins site on (b)(6) 2024, possible loose connection.The rep was in the operating room supporting a system revision.The patient came in for a revision on (b)(6) 2024 due to out of range impedances on contacts 1,4,6 and 7; it was also reported that contacts 1,5,6, and 7 were high and out of range.Their lead was directly connected to the ins.Upon disconnecting the lead, there was some material/debris on the lead surface which was removed using a swab. the impedances were tested using a wireless external neurostimulator (wens) and confirmed to be back in range (except for contact 0).The surgeon connected the lead back into the original ins, but in port 8-15 which was previously plugged.The clinician programmer (clp) was used to disconnect from the wens and reconnect to the ins, where the impedances were checked through the ins and confirmed to be in range (except for 0).The session was ended and the surgeon finished the case.The device was retightened and it was closed. the healthcare provider (hcp) could successfully establish communication with the ins, before the revision, with the wens, during the revision, and again with the ins once the battery was connected to the new lead.However, during this second interrogation session with the ins, the hcp forced closed the app, without ending the session as intended. immediately post-op, when trying to interrogate the ins in recovery - the ins was detected, communication went up to 100 (the telemetry loading bar reached 100%), but then a 'system error - code-0x3bdf345a' came up on the screen.The rep saw system error every time they try and interrogate the ins; this happens when using both the manufacturer representative's (rep's) tablet and the clinician tablet. this prevents the rep from communicating with the ins and setting any stimulation programs.They knew that this could be due to the pds being in deep sleep, so they opened the pds application and tried again. they've tried the settings that they've been sent previously and it was still not working.Technical services responded that a system error means that the app encountered an unexpected error.Normally this error is handled by android by terminating the running application.They cannot determine what happened based on the code.The nature of the code is not always meaningful. they tried multiple times and could not connect.The patient programmer would connect, but the programs could not be updated so she could not turn on her therapy.There were no patient factors as to why they could not connect with the clp as it has previously connected to the ins twice that day with no issues. the patient was dismissed by the hospital but the ins was off.When the rep tried to use the patient controller(ptm), it seemed that the programmer was showing the old group (a and b, while the hcp set only group a).However, because the old group was set on a dismissed channel, the ptm immediately prompted the oor message.They were getting oor on group a so two additional programs were added in b and c to allow to reduce amplitude.Technical services noted that this indicates that the ins is still able to communicate with the ptm, however, somehow the new stimulation settings were not saved and the rep cannot communicate with the ins using the tablet. the rep saw the patient in the clinic on 2024-feb-05.They attempted to i nterrogate the device using three clp, having followed troubleshooting tips provided by technical services.'system error - code 0x193e6af8' was seen on the first attempt at 10:33, and 'system error - code 0x4169b438' seen on second interrogation attempt (10:38am).These errors were seen after the ins was detected and communication ran up to 100. they used the patient programmer to disable the ins and then enable.The ins then started to recharge as it showed it was too low to turn stimulation on.They charged for approximately 15 minutes until it went from red to green (approximately 30%).They then tried to interrogate again using the clp but saw the error code 'system error - code 0x193e6af8' at 11:11am.The rep disabled and enabled the device three times in total.They also unpaired and re-paired the programmer to the ins.The rep did notice that after the second disable/enable the battery charge for the ins did show at 60% (previously they charged up to 30%). all tablets were updated to the correct versions.They restarted all tablets and opened/closed patient data service (pds). patient now has no therapy and is in a lot of pain.The issue was not resolved at the time of the report.The patient was alive with no injury at the time of the report. additional information was received.It was reported that the cause of the system error code was not determined.The further actions taken to resolve the issue were that device logs and reports were sent to technical services in the us to be analyzed; the hcp is waiting for a response.The system error, communication issue, and the new settings not being saved were not resolved; they will wait for further instructions once the logs and reports have been analyzed by the us.This issue is unresolved and the patient is now without therapy and in a lot of pain.They plan to revise if the issues are continued.

Manufacturer Narrative

Continuation of d10: product id 977a1 lot# serial# unknown implanted: (b)(6) 2019 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 977a1, serial/lot #: unknown, b3.Date is month and year valid.G2.Foreign: united kingdom.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.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: continuation of d10: product id 977a290 lot# va1z6xw037 implanted: (b)(6) 2019 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.

• 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: 18722639
• MDR Text Key: 335709520
• Report Number: 3004209178-2024-04999
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Date Device Manufactured: 07/14/2018
• 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
• Treatment: "SEE H11...."
• Patient Outcome(s): Required Intervention
• Patient Sex: Female