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

Model Number 97800

Device Problems Energy Output Problem (1431); Vibration (1674)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Discomfort (2330)

Event Date 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

Date is approximate.Month and year are confirmed valid.Event date is not known.Please see event for approximate date range, if applicable.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 for the first few days after implant, they had an electrical pain in their left testicle and an annoying vibrating sensation. patient said that the pain has completely gone away and is 75% normal.The patient was redirected to their healthcare provider to further address the issue. initially the patient said it was painful for the first ten days to two weeks.Asked him to clarify and he said he thinks it's from the stimulation and the area from the surgery.It could get annoying when pulsing.

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 patient called back to ask for assistance to turn their therapy up since they had a ban incident in the last 24-48 hours.However, they mentioned they got therapeutic benefit.The patient also stated they're unable to lie down on the side where the device was implanted since it's still too painful, they can't wear jeans because they come right across, and they wish they'd find a different place to put the implant.They also had issues with the sterile strips, and their wound was still irritated and bleeding after 4-5 weeks.They saw their local doctor, and they gave them mepilex borderflex dressing.They said we should consider switching to this dressing since they had trouble with the one they were given; it's a mess, it sticks to everything on the way there, and they can't put it on easily.Assisted the patient with increasing stimulation.Confirmed stimulation is in the bicycle seat, which is comfortable.Redirected to hcp to further address issue.

• 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: 19041577
• MDR Text Key: 340111071
• Report Number: 3004209178-2024-08468
• 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: 05/01/2024

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: 03/27/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 05/01/2024
• Date Device Manufactured: 01/17/2024
• 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: 75 YR
• Patient Sex: Male