MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97714

Device Problems Intermittent Continuity (1121); Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); Battery Problem (2885); Charging Problem (2892)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

Event Type  malfunction  

Event Description

Information was received from a consumer via a manufacturer¿s representative regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient complains that the ins switches off itself about one time a week.She complains about trouble to recharge the ins (about 2 hours each session, but she never succeed in fully recharging the ins). no environmental/external/patient factors that may have led or contributed to the issue have been identified. no diagnostics/troubleshooting have been performed. a new recharger will be sent to the patient.The issue was not resolved at the time of the report.The patient status at the time of the report was alive with no injury.Additional information was received from a manufacturer representative (rep).It was reported that, regarding the ins turning off each week, no cause of the issue has been clearly identified.They suppose that issues with the recharger could be a reason but it was not confirmed by the patient.The rep will report when they have more information from the patient regarding whether the replacement recharger resolved this issue or not.They asked the patient to identify common factors when the ins was switching off (battery level, place, activity ¿) and the data report was shared with technical services for analysis which could give more information.The issue has not been resolved.A new recharger has been sent to the patient.The ins could be replaced if they are not able to resolve the issue.The provided information has been confirmed with the physician/account.Additional information was received from technical services.It was reported that they can see some loss of stimulation records, however it is very hard to see when they occurred because lately the time of the ins is incorrect and has been reset to (b)(6) 2000.With the last 6 recharge sessions it is also very hard to read the data because the date and time of the ins are incorrect.What they do see is that the last loss of stimulation corresponds to (b)(6) 2000, where they can also see that the battery level was very low.This means that this loss of stimulation is likely caused by a depleted battery.The date of the ins will reset to (b)(6) 2000 when a por (power-on reset) occurs, in the data report they could see that one por occurred on the (b)(6), likely cause by emi.This is probably the reason the date and time reset to (b)(6) 2000.For the other loss of stimulation entries they could not find anything in the data report, which gives a first indication that the loss of stimulation records might also be related to a depleted battery.For what concerns the long recharge duration, in the records they only see recharge sessions of 1.5 hours max, and within this time they see that the battery increases well.To fully charge a restore ins, the patient might need 4 hours with the wireless recharger.Additional information was received.It was reported that the por was due to a parity error.

Manufacturer Narrative

France 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 reported that, regarding the cause of the cause of the ins turning off each week, given that the patient has never had any issue again since the recharger has been replaced (december 18th 2023), the cause could be the previous recharger or that the patient did not recharge as frequently as needed.The replacement recharger has resolved this issue.For now, no further actions are planned because the issue seems to be resolved.The provided information has been confirmed with the physician/account.

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: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18387359
• MDR Text Key: 331492526
• Report Number: 2182207-2023-02877
• Device Sequence Number: 1
• Product Code: LGW
• 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: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2024
• 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