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

Model Number 97800

Device Problems Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Overheating of Device (1437)

Patient Problems Burning Sensation (2146); Discomfort (2330); Insufficient Information (4580)

Event Date 04/27/2023

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.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 fecal incontinence and urinary dysfunction/sacral nerve stim.The reason for call was patient has been experiencing a very strong stinging and burning sensation around where the ins battery is.Patient was inquiring about ins flipping/movement/dislodgement after changing the sheets on their bed today.Patient said they can easily feel their implant close to the skin and they can sort of feel movement/move the ins around.Patient said they have taken 2 tylenol pills for the pain at 7:35 this morning and at the time of call, they can feel the sensation coming back a little bit but not as intense.Patient said it feels warm like it's burning.Patient said one side of the incision is more sensitive than the other.Patient said it's not bleeding but it's definitely red where the incision is.Reviewed purpose of implant placement/location, reviewed feeling for the ins/telemetry and reviewed every day activities.Reviewed therapy optimization options for uncomfortable stimulation sensations and patient confirmed that they were not feeling stim, the sensations are from the incision site alone.Redirected patient to hcp to discuss healing process.The patient's relevant medical history included patient said they got the implant because they were having smearing issues with their bowels and mentioned they had black in their feces.

• 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: 16939754
• MDR Text Key: 315315412
• Report Number: 3004209178-2023-06526
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• 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
• Date Manufacturer Received: 04/27/2023
• Date Device Manufactured: 03/07/2023
• 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: 72 YR
• Patient Sex: Female