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

Model Number 3058

Device Problems Electromagnetic Interference (1194); Entrapment of Device (1212); Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: other applicable components are: product id: 3889-28, lot#: va17jc9, implanted: (b)(6) 2016, product type: lead.Other relevant device(s) are: product id: 3889-28, serial/lot#: (b)(4), ubd: 08-jun-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.The patient said that for the last six months it hadn't been working and the patient was having problems with their bowels.The patient decided to turn stimulation off and hadn't been using the therapy.They said they had a colonoscopy on (b)(6) 2020 and was told that the wire from the implant was in the colon.They commented that they wondered if that was where it had been placed from the beginning.The patient said they were scheduled to have the complete system removed on friday.Information was reviewed and the patient was redirected to consult with their healthcare providers and it was requested the patient provide an update after procedure.No further complications were reported or anticipated.

Event Description

Additional information was received.It was reported that the device had been explanted on (b)(6) 2020.It was clarified that the lead had been pulled into the rectal stump by the provider while they were performing a routine colonoscopy.The device had been functional prior to the colonoscopy.The physician performing the colonoscopy called the managing physician for advice as how to proceed.

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.

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.The healthcare provider called regarding the letter.They reported that the allegations reported were not true or correct and misrepresented.They indicated the healthcare provider performed a colonoscopy and saw a bump and pulled the device into the rectal stump.They also reported the patient had a rectal bypass and does not have a rectum, so nothing was ever in the colon.The caller then indicated the lead and ins may have been pulled into the rectal stump by accident.At the time it was recommended the caller put this into writing, caller was going to have the hcp write a letter and return it to the manufacturer.

Event Description

It was reported that the patient had the device removed on june 5th.The patient said he has been having problems with the device just about since he got it.The lead had also worked its way out of his bladder and got into his colon.The patient said the lead worked its way into the colon is the main reason he had the device removed.The patient said he had to endure a lot of pain because of the device.The patient said the doctor has the device and did not tell him what they were going to do with it.No further patient complications are anticipated or expected as a result of this event.

Manufacturer Narrative

Continuation of d11: product id 3889-28, lot# va17jc9, implanted: (b)(6) 2016, explanted: (b)(6) 2020, product type: lead.H6: code refers to the lead implant.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 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
• MDR Report Key: 10123804
• MDR Text Key: 196765056
• Report Number: 3004209178-2020-09794
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/24/2020

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 Expiration Date: 01/28/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 06/09/2020; 06/15/2020; 06/17/2020
• Supplement Dates FDA Received: 06/11/2020; 06/17/2020; 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 86