MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number 97800

Device Problems Electromagnetic Interference (1194); Data Problem (3196)

Patient Problems Micturition Urgency (1871); Incontinence (1928)

Event Date 07/01/2023

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that last (b)(6) 2023, they had to go through security at the airport and they thought they just needed to turn off their external devices so they did and then walked through security with their ins on.The patient stated when they got home, they had to run to the bathroom really quickly and they barely made it and had to change their pad.The patient stated they checked their settings at that point and the stimulation had gone down to really low.Patient stated going through security with the ins on caused the stimulation to change on its own.Patient services reviewed with the patient that it would be highly unlikely that the stimulation would change on its own and tried to clarify with the patient if they had possibly made a change to their settings like changed to a new program and just didn't increase the stimulation at that time however the patient insisted that the sti mulation had been high and going through made it lower.They noted that hadn't happened again however though they hadn't been back to the airport since then.Patient services reviewed airport security compatibility guidelines.The patient stated they told the tsa agent last july they had an implant but they said "you'll be ok, just go through." the patient stated they were flying again soon and was going to be sure to turn the therapy off before walking through.Patient services reviewed with the patient to call back if they noticed this happened again.Patient had called because they were reading in the labeling about turning the therapy off before going through security and they understood that now but the labeling didn't say what would happen to their symptoms when they turned it off.Patient services reviewed information with the patient that with the therapy not being delivered, the patient would not be getting it and if they wanted therapy to turn the therapy back on after they get through security.Patient stated they would go to the bathroom when they were finished and turn the therapy back on.Documented reported event.No further action was taken by patient services.

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed 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 the patient.It was reported that the patient corrected the issue by adjusting the programmer.The patient had recently travelled and everything went well.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: INTERSTIM X
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• 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: 18890820
• MDR Text Key: 337556727
• Report Number: 3004209178-2024-06937
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: 00763000484668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2024
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/20/2024
• Date Device Manufactured: 12/08/2022
• 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 Age: 70 YR
• Patient Sex: Female