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 Flatus (1865); Incontinence (1928); Urinary Retention (2119); Discomfort (2330); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 01/09/2024

Event Type  Injury  

Manufacturer Narrative

B2: retention 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 dysfunction/sacral nerve stim.It was reported that the patient was trying to reach the manufacturing representative (rep) because they wanted to know if it was safe to up their stimulation again. they didn't know that it is doing anything at this point.Once in a while will empty into the toilet but really rare.It feels like there is gas pockets in the colon.If they tried to pass the gas then it would flush out.They were getting less than 50% relief of symptoms.The symptoms fluctuated quite a bit.They had a very difficult surgery.The device restricted all the bladder evacuating.They left it on the lowest it could be.They waited about two weeks and it started to get more normal.Now it always evacuates or flushes and fills the whole pad.By the time they get to the toilet there is very little left to go.When not urging or not evacuating at all they could sit there for 20 minutes after they got the urge to sit on the toilet and nothing happened.Now they were just flushing and flushing.Patient would say they were changing pads and pants more than ever before, and they had to wear plastic pants.Patient doesn't feel vibration when they  would bend over.They talked to the  rep maybe four weeks ago and they upped the strength and it was better.The other thing is they had quite a lot of discomfort on the left side from the back of their thigh right above the knee.Their whole lower left leg was swollen and they didn't know if it is related to the device or not.They had a couple tests done in the hospital in the imaging center.They looked for clots and they didn't see anything.When the patient would lay on the side of their device or they turned at night they would feel a kind of pinching feeling.Patient said they though their symptoms are worse then they were before the implant.

• 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: 19081944
• MDR Text Key: 339844711
• Report Number: 3004209178-2024-08834
• 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
• Report Date: 04/10/2024

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: 04/05/2024
• Initial Date FDA Received: 04/10/2024
• Date Device Manufactured: 11/13/2023
• 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): Other
• Patient Age: 77 YR
• Patient Sex: Female