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

Model Number 97714

Device Problems Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); Battery Problem (2885)

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

Event Date 10/01/2023

Event Type  malfunction  

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that back in october of last year, the patient suddenly received a por notification, and it could be seen that the implanted neurostimulator (ins) had reset itself.For a while it seemed to be fine but now the ins sometimes fails again.Only this time, they don¿t not get any notification.They can switch the system back on again.No symptoms were reported.Additional information was received.Implant date confirmed, clarification of ¿ins sometimes fails again¿ statement is not known.Re garding actions taken, the ins has been checked, but its not on cycling.All impedances were fine.Data and session reports provided.The issue has not resolved.Additional information was received.The session report was analyzed by technical services (ts) who concluded the following: ¿unfortunately, they did not see the por message they were talking about in the data report, but that could be because it took place before (b)(6), and the report only has information from after (b)(6) 2023.Next, we see that the ins was turned off around (b)(6).However, we see no por or loss of stimulation due to dead battery on these days.In both the data and the session report, it is shown as a manual action with the remote control.In case it is about an automatic shutdown of the system, a purple bullet would be in the session report, which was not the case.Also in the data, there was nothing under 'loss of stimulation'.We do indeed see in the session report and data report what the patient indicates, only our statement (about a manual action) does not quite match what the patient indicates.Could therefore try giving a different controller.Fur thermore, we see no link to the por before (b)(6), the battery has not been in overdischarge according to the report.¿ additional information was received.Further clarification was received from the nurse regarding the statement ¿ins sometimes fails again.Only this time, they don¿t not get any notification".The nurse stated that normally, the patient feels the stim, but then suddenly the stim was turning off, without any notice.If the patient looks at the programmer, they do not see the lighting-symbol for the ins anymore.They turn the stim on again with their programmer, and the lightning-symbol appears again.The patient is receiving therapy again, except for the moments that it turns off.To resolve, the patient programmer is going to be replaced but this has not yet occurred.

Manufacturer Narrative

B3: month and year valid.G2.Foreign: netherlands.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

Continuation of d10: product id neu_unknown, serial# unknown, product type: unknown.Corrections: b1: changed to adverse event, product problem.Coding updates: imf code changed to f11.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 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: 18778767
• MDR Text Key: 337427116
• Report Number: 3004209178-2024-05694
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Date Device Manufactured: 05/17/2017
• 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...."