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

Model Number 97800

Device Problems Electromagnetic Interference (1194); Failure to Interrogate (1332); Communication or Transmission Problem (2896); Data Problem (3196)

Patient Problems Incontinence (1928); Distress (2329)

Event Date 11/30/2022

Event Type  malfunction  

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

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 they were having trouble with the handset and communicator and stated it takes multiple attempts to connect to the implanted neurostimulator.Patient said when they are trying to connect, they will see 'device not found' and will have to retry several times to connect.Patient said recently they took a cruise and every time they got on or off the ship, they had to go around the security gates but they wondered if that interfered with their ins because they noticed they were having a hard time with this issue when they came back, around (b)(6)2023.Patient said they think there's something wrong with their communicator and that is why they are having issues.They said they have to charge it daily, because it loses charge really fast.Patient said that when they charge it, the battery light is orange, then it starts flashing green and eventually will be a solid green.Patient said they noticed this a few times in the last couple weeks.Patient stated they had a terrible accident yesterday and the co mmunicator wasn't charged so when they tried connecting to their ins to change to a new program, they kept seeing 'device not found' and took about 10 attempts to connect to their ins.Patient said they finally got it to connect, but said they tried changing programs and it "went back to the same program" so they got frustrated and turned off the devices (patient did not elaborate on it "went back to the same program").Patient also said that recently, after they got back from their cruise, they were at the airport and they were trying to power off their ins to go into security, but they kept getting 'device not found' and it took a really long time to try to find the ins, but they ended up not being able to find the ins to turn their ins off.Patient said maybe it was because of all the emi, but they aren't sure.Agent reviewed communicator battery lights and charging and handset and communicator bluetooth connectivity vs external device and ins telemetry.Confirmed patient was not using communicator while plugged into charging cord, con firmed communicator was powered on, confirmed how to make sure external devices are connected before connecting to ins, confirmed patient was using correct therapy application.Reviewed external device batteries vs ins battery and reviewed emi interactions.Redirected patient to hcit to see if there was a handset issue and recommended patient call back if there is a battery issue with communicator.

Event Description

Additional information was received from the patient.They reported that the emi may have affected the device.The cause of the changing programs was not determined.It was most likely due to the handset not powering on.Patient called tech services and they instructed them to reboot the device but the problems continued.Ts determined a new device would be needed.It was reported that the issue was resolved.The cause of the communication issues were not determined but were most likely due to the handset not powering on.It was reported that the issue was resolved.The cause of the communicator battery issues were not determined.

Manufacturer Narrative

Continuation of d10: product id: tm90q0, serial# (b)(6), product type: accessory.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: 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: 18110738
• MDR Text Key: 329113220
• Report Number: 3004209178-2023-20088
• 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: 02/28/2024

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: 04/14/2024
• 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: 11/06/2023
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 02/28/2024
• Date Device Manufactured: 10/20/2022
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 64 KG