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

Model Number 97800

Device Problem Malposition of Device (2616)

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Diarrhea (1811); Pain (1994); Malaise (2359); Constipation (3274); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 03/21/2024

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and fecal incontinence.It was reported that they had the worst diarrhea they've ever had the same day after the surgery.Patient said they had cramps, stomach cramps and diarrhea that day and the next day they started feeling constipated.The patient called their doctor and the doctor said it could be from the anesthesia or antibiotics.Patient reported they were sick for about 4 hours and it was terrible.They said they had a surgery one month before, and they didn't have any side effect.Patient mentioned they were eating normal meals and this morning they went to the bathroom and had a normal bowel movement, and they didn't know if it took time for it to regulate itself.They stated they were feeling better.Patient services reviewed therapy information and general programming guidance.Patient stated that the area where the device was implanted, it still hurt if they sat on it, and they could feel it was pretty deep, and it is swollen, and they were afraid it was going to pop out.Patient said will track symptoms for the next 3¿4 days or a week before making any changes in the therapy and will call back if they need assistance to do so.The patient was redirected to their healthcare provider to further address the issue.Patient noted they have a follow-up appointment with their doctor in 4¿6 weeks. patient declined device education.The patient said they reviewed everything about usage with their manufacturer representative (rep) before, and they felt comfortable using the device.

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 healthcare provider (hcp).The patient did not have an infection.When asked about the device being too deep, they responded "n/a".

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: 19081921
• MDR Text Key: 340688324
• Report Number: 3004209178-2024-08832
• 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: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

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?: Yes
• Device Operator: Health Professional
• 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: 03/25/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 05/01/2024
• Date Device Manufactured: 12/05/2023
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 52 KG