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

Model Number 3058

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

Patient Problems Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Scar Tissue (2060); Skin Erosion (2075); Impaired Healing (2378); Ambulation Difficulties (2544); Caustic/Chemical Burns (2549); Full thickness (Third Degree) Burn (2696); Skin Inflammation/ Irritation (4545); Insufficient Information (4580)

Event Date 04/05/2021

Event Type  Injury  

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.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that, two days after implant surgery, the patient reported having a huge blister under the incision and the skin started falling off.Patient said it was about six inches below the incision and five inches wide.Patient said that it was third degree burns and when they contacted hcp about this a week after implant, no explanation was provided, said that it looks like a chemical burn however hcp wouldn't treat the site and didn't provide any pain medication.Patient said was unable to sit down, wear clothes or pull pants down.Patient said that it was excruciating and painful.Patient said that they got some burn cream and pcp prescribed some silver sulfate cream (for burns).Patient said that it took six months to heal and has a terrible scar.Patient said as a result they are very hesitant about going back to that hcp.Documented reported event.No further action was taken by patient services.

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.

Event Description

Additional information was received from the patient.It was reported that the patient called back and she mentioned about the burn again.Patient said, she confronted the doctor and he said he doesn't know what happened.He said, it could be a chemical burn.She said, the therapy it is not working.It is turned off.Doesn't know why it is turned off.Patient services (ps) offered to help her connect the device.She said, when she powers on the handset it is just blue and has my files, galleries, and my settings.Patient was upset and didn't want to talk to ps.She wanted to talk to someone else.Transferred caller to another agent.Spoke with patient on 28-nov-2022.Patient was escalated.Patient said they got a burn on their hip.Patient said they are still in diapers.Patient said the healthcare provider (hcp) wouldn't treat the burn.Patient said they had 3rd degree burn if not worse.Patient said they have a 6x6 circle, patient said it was some kind of chemical burn.Patient said their skin was melting off.Patient said the hcp couldn't explain how it happened.Patient said the device doesn't work for them and never has.Patient said the scar is horrible looking.Patient said their personal life is over.Patient said the device hasn't made any difference in their life.Patient said the burn took forever to heal and was bleeding.Patient said they couldn't sit down for 4 months.Patient said they have gotten nowhere with the product.Patient said the hcp didn't care what they did.Patient said it was very painful for months and they couldn't sit in a seat.Patient said they are still wearing pull up and their 30 year relationship is destroyed because of it.Patient said they didn't see the my therapy app on the handset.Consulted mobility after turning power save mode off the patient was able to access the app.Reopened and reassigned case to email patient hcp listings.

• Brand Name: INTERSTIM II
• 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: 15601092
• MDR Text Key: 301712403
• Report Number: 3004209178-2022-13377
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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,Followup
• Report Date: 12/16/2022

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: 07/14/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 12/16/2022
• Date Device Manufactured: 01/21/2021
• 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): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female