MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number NEU_INTERSTIM_INS

Device Problems Migration or Expulsion of Device (1395); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 978a128, implanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 978a128.If information is provided in the future, a supplemental report will be issued.

Event Description

Information received from the healthcare professional (hcp) via manufacturer representative (rep) reported a micro lead migration.There was a migration of the lead to extension connector into the tunneling path leading from future ins pocket site towards the extension exit site.The physician had to ask for fluoroscopy support and had to make a new incision in order to open the connection.More or time for physician and a new incision for the patient.The event seems to be a result of the brand new tunneling technique/connection lead to percutaneous extension.The physician used the trocar tip for tunneling this time.Actions taken was support by fluoroscopy and a new incision was made in order to disconnect the percutaneous extension.The issue was resolved and a surgical intervention occurred.Additional information received reported the issue concerned the first micro lead implant.Additional information received reported that the contributing factors was most likely the new tunneling technique in which the carrier tip widens the tunnel that caused migration.In the previous system, one would tunnel the twistlock connection, the tunneling route therefore was smaller than the size of the connection piece.There was no issues in the past with old tunneling techniques.The size of the pocket site was as small as possible, the lead and extension were coiled neatly, and the excess cable was coiled neatly plus fixed with bandages.

Manufacturer Narrative

Continuation of d11: product id 978a128 lot# unknown serial# implanted: (b)(6) 2020 explanted: product type lead.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 received reported that the procedure instructions should be adjusted saying that the connection needs to be fixed in the pocket.

Manufacturer Narrative

Continuation of d11: product id: 978a128, implanted: (b)(6) 2020, product type: lead.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.

Event Description

Additional information received reported that on the (b)(6) of (b)(6), they worked with new devices.It was reported that they did 4 1st stage procedures and 2 weeks after, they performed 3 2nd stage procedures and 1 removal of the lead.The new tunneling device was the cause of the migration of the connection cable.Since the connection piece was thicker and the canal you get from using the newtunneling device is wider.Therefore, some traction on the connection cable can cause the connection piece to migrate into the canal.It was reported that they experienced it on all 4 procedures.The hcp reported that they changed their procedure and have never experienced migration again.

Manufacturer Narrative

Continuation of d10: product id: 978a128; lot# unknown; implanted: (b)(6) 2020; product type: lead.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
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 9771158
• MDR Text Key: 188484858
• Report Number: 6000030-2020-00070
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/16/2021

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 Model Number: NEU_INTERSTIM_INS
• Device Catalogue Number: NEU_INTERSTIM_INS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 08/14/2020; 09/25/2020; 04/16/2021
• Supplement Dates FDA Received: 09/11/2020; 10/05/2020; 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention