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

Model Number 97800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Bacterial Infection (1735); Diarrhea (1811); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Skin Discoloration (2074); Impaired Healing (2378); Weight Changes (2607); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 08/10/2022

Event Type  Injury  

Manufacturer Narrative

Date of event: date is estimated; month and year are valid.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 urinary/bowel dysfunction and fecal incontinence.It was reported that since middle of august, they noticed that the ins incision site was not healing correctly, wasn't closing up.Patient said it was red, smelly and stuff was coming out of the area, and said it was also swollen and painful.Patient said that they did notify their health care provider (hcp) and was told that it would take a while to heal and said that they removed the wire and didn't say anything about replacing the wire.Patient said they were told that they had an infection in their intestines, "said you have an infection here and you have an infection there," and placed on other medication.Patient said they had to take 3/day 500mg.Each.Patient said then they were told that they had a staph infection at incision site.Patient said eventually they received antibiotics: 5/day 500 mg.Each for 10 days, however said that the incision site still wasn't healing and was still black and reddish looking. patient said that ins was removed on (b)(6) 2022 by implanting hcp at [hospital].Patient said they had been seen twice since surgery, saw hcp and about 1-2 weeks ago saw the nurse practitioner who said to keep changing the bandage daily and cleaning out with peroxide and should heal by itself and don't need to come to office again.Patient said they aren't sure if it is properly healing at this time, still black and bloody.Patient to monitor incision site and follow up with hcp if they have any concerns about the healing of the incision site.  patient reported that without the implant to stimulate intestines patient was having diarrhea so bad and kept on losing weight and right now weighs 99 lbs. patient services redirected patient to check with hcp office regarding when and if the lead was removed.Agent later researched if lead was removed as well and called patient - verified full system was removed due to infection.

Manufacturer Narrative

Explant date was not included in initial report, correction sent, see d6b for explant date.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 INCONTINENCE
• 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: 15845165
• MDR Text Key: 304125217
• Report Number: 3004209178-2022-15408
• 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,Followup
• Report Date: 01/31/2023

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: 10/28/2023
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 01/13/2023
• Supplement Dates FDA Received: 01/31/2023
• Date Device Manufactured: 05/09/2022
• 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): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 46 KG