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

Model Number 97800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Urinary Frequency (2275); Discomfort (2330); Prolapse (2475); Urinary Incontinence (4572)

Event Date 02/22/2024

Event Type  Injury  

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.

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 the patient noticed a return of frequency in urination about a week ago.Unable to ask if any changes might have contributed to the change as patient stated was receiving an important call from a doctor's office and unable to continue this conversation.As a result, troubleshooting was unable to be performed.The patient was redirected to their healthcare provider to further address the issue.Earlier in the conversation reviewed therapy information and general programming guidance.Patient said that will be going to managing physician's office every three months and hoping that they will just make the adjustments.The patient's relevant medical history included that patient has a history of colon prolapse and right after they received the implant they experienced an emergency with this condition.Patient said therapy was turned off and wasn't turned back on until (b)(6) after the medical emergency with colon was addressed.Patient said they are scheduled for colon surgery at the end of march.

Event Description

Additional information was received from the patient.Patient called back to report that due to their colon prolapse outside of their rectum, it was applying pressure on their bladder so their bladder wasn't responding as well to the therapy/the therapy wasn't working at full capacity.Patient stated they had to stay close to the bathroom as a result.The patient stated they were scheduled for surgery to address the prolapse on (b)(6) 2024 and in the meantime they were just leaving the therapy on but not worrying about trying to work with it to achieve better therapy results.Patient also reported they had been in the hospital recently and they discovered a small bowel blockage.Patient confirmed the blockage was unrelated to the device/therapy.Patient mentioned being in a fib when they were in the hospital and that they had to see a heart specialist for swelling in their right leg and ankle but it was determined they had no blood clots.Patient inquired about a nuclear stress test coming up.Patient services reviewed information with the patient.The patient also mentioned they had so many different tests and procedures going on that their brain was a little foggy and they didn't remember how to turn the ins off.Patient services reviewed with the patient to call back if they needed assistance with turning the therapy off in the future.Patient stated they would call back to review in the future and that they would direct their hcps to call technical services if they had any questions about the device/therapy.

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.

Event Description

Additional information was received from the patient.The caller stated that due to the prolapse, they were experiencing bladder pressure and uti's (unrelated).All questions were addressed, and the patient will call ps if they are in need of further assistance with the external equipment.

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: 18994571
• MDR Text Key: 338884675
• Report Number: 3004209178-2024-08017
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/02/2024; 05/17/2024
• Supplement Dates FDA Received: 04/30/2024; 05/21/2024
• Date Device Manufactured: 10/23/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female