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 Incontinence (1928); Nerve Damage (1979); Pain (1994); Anxiety (2328); Depression (2361); Insufficient Information (4580)

Event Date 03/11/2022

Event Type  Injury  

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 has gotten no follow up from the manufacturing representative (rep) or surgeon despite reaching out.Patient said they had to turn stim off because it was causing problems.Patient said the ins site was very painful and still is.Patient felt a thumping sensation and shooting down their legs.Patient said they have gone through the different programs.Patient said they turned stim off and there was no change in their symptoms w/ stim off.Patient said the device was not helping their symptoms and now they have pain.Patient said this past week they had a little fecal incontinence which was really freaking them out.Patient said they feel abandoned and don't want the device in them.Patient said the surgeon got in trouble and lost their license for pushing the interstim device and not trying other treatment for ic 1st.Patient said they called the surgery center and was told they would have a rep call the patient but the none of the rep's are calling the patient back.Patient said this sent them into quite a depression and they are now in therapy.Patient said they don't know if they want the device in them anymore, patient said they want to try different treatment for ic.On sep 14th they talked to someone at the manufacturer who told the patient a rep would call the patient in 24 hours but the patient never heard from anyone, patient doesn't know who they talked to.Patient said they can't function.Patient said their follow up appointment was a week after implant and all they did was remove the stitches.They are concerned about nerve damage and their situation is very distressing.Patient requested that pss follow up w/ the patient as they would like to have a connection to someone.Patient asked about cost, reviewed warranty info.  agent did not ask about the circumstances that led to the reported issue.Notifying field staff of situation or request.

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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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: 15788140
• MDR Text Key: 303558091
• Report Number: 3004209178-2022-14956
• 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
• Report Date: 11/14/2022

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 Expiration Date: 06/14/2023
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/14/2022
• Date Device Manufactured: 12/15/2021
• 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: 51 YR
• Patient Sex: Female