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

Model Number 97702

Device Problems Display or Visual Feedback Problem (1184); Energy Output Problem (1431); Device Difficult to Program or Calibrate (1496); Unable to Obtain Readings (1516); Low impedance (2285); Battery Problem (2885); Insufficient Information (3190); Data Problem (3196)

Patient Problem Pain (1994)

Event Date 10/01/2023

Event Type  malfunction  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient has felt a decrease of the pain relief for hours.Before sleeping, they wanted to use their remote controller to reduce the intensity of the stimulation but an error appeared on the remote controller (574).The implantable neurostimulator (ins) can not be reprogrammed, the intensity can not be changed. when monitoring the ins with the physician programmer n'vision, an error appeared : cbasetelemetry.Cpp 367 (38). when monitoring the ins with the clinician tablet, a validation error appeared : ad 01 00 00 (also reported as 1a 01 00 00) ; and then system error 0x26014e99. no environmental/external/patient factors that may have led or contributed to the issue have been identified. the stimulation has been switched off.The issue was not resolved at the time of report.Additional information was received from a manufacturer representative.It was reported that the rep doesn't think that the patient also saw error code 517 on the patient programmer.The patient could still feel the stimulation.It was unknown if it was a ct900e, but the rep is due to see the patient with the nurses on (b)(6) 2023 and they will have a look at the tablet version.No cause of the errors/inability to program or change intensity has been determined, unless the programs were corrupted.Indeed, deleting these existing groups with nvision resolved the problem.The issue has been resolved.To do this, they tried to communicate with a nvision controller and not the samsung tab.They were able to delete the 2 existing (and possibly corrupted) programming groups and reprogram a new one from scratch.Thanks to this, they were then able to find a new program of spinal cord stimulation (scs) working well, the error message on the remote controller (97740) disappeared, and the rep was then able to communicate with the physician tab without error message.The provided information has been confirmed with the physician/account.The tablet used was a ct900d.The patient was programmed with 2 different groups, but it was impossible to switch from one to the other.When the rep tried this morning ((b)(6)2023) with their programming tablet (also a ct900d), they got exactly the same error messages.So they tried again with the n'vision.They were able to create a new programming group (c) which was functional.They then deleted the 2 old groups that seemed corrupted (a and b) and the new programmed group worked fine.The error message on the 97740 remote control was no longer present, and the rep was then able to reconnect with their tablet.A session report was provided which showed that there were low impedances read as "<(><<)>50" and an invalid reading of "xx".The session report also showed that the time of the device is shifted by more 90 minutes compared to the programmer.There were conflicting reports of the implant date, (b)(6) 2018 and (b)(6) 2018.

Manufacturer Narrative

D.6a.Date and month valid.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

Additional information was received from a manufacturer representative.It was confirmed that the ins was implanted the (b)(6) 2018 but the first programming session was done the (b)(6) 2018.The time and date of the device has not been manually updated.This time difference must be explained because the clinician programmer which was used to program the device last time was not on time.The time and date of the ins should be updated at the next session programming (not scheduled for now).No actions were taken or are planned to resolve the low impedances and invalid measurements.

Manufacturer Narrative

G2.Foreign: france correction to b5.N'vision displays error 379 (38), not 376.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.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

Additional information was received.It was stated that additional logs were needed regarding this case.Technical services (ts) wanted the logs from the event when they were unable to switch groups.It appears that the battery had been interrogated twice that day ((b)(6) 2023), but the logs have an earlier timestamp compared to the one of the report.The manufacturer representative (rep) indicated that the nurses in charge of the patient have told them that they have no further documents than those that were sent.However, the ins has just shown an elective replacement indicator (eri status).It will therefore soon be explanted.It can therefore be sent for further analysis.

• Brand Name: SURESCAN
• 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: 17977803
• MDR Text Key: 326187902
• Report Number: 3004209178-2023-18045
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2024

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: 06/28/2019
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 10/17/2023; 01/30/2024
• Supplement Dates FDA Received: 11/01/2023; 02/05/2024
• Date Device Manufactured: 01/13/2018
• 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
• Patient Sex: Female