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

Model Number 97800

Device Problems Break (1069); Difficult to Remove (1528); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2023

Event Type  Injury  

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed valid.B3: date is approximate.Year is confirmed valid.B3: event date is not known.Please see b5 for approximate date range, if applicable.Section d references the main component of the system.Other medical products in use during the event include: brand name surescan; product id 978b128 (lot: va2m3ge); product type: 0200-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

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's stimulator lead, broke inside of them they think in august or september so they decided to have it taken out but the urological surgeon who removed it, said there was a tip of the lead that he could not get out and it would probably cause more harm to continue trying to remove it.Patient said now they need an mri of their hip but the mri facility does not want to do it because the tip is still in there.Patient was calling for mri information.Reviewed information about mri and redirected to their doctor.The patient mentioned other medical history.This included patient said they did not have any falls or traumatic accidents, they had no other medical tests or procedures.See 705789055 for information regarding revision.

Event Description

Additional information was received from the patient.They reported that the device also stopped functioning.

Manufacturer Narrative

Continuation of d10: product id 978b128, lot# va2m3ge, implanted: (b)(6) 2022, explanted: (b)(6) 2024, 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 was received from a healthcare professional (hcp).When asked the hcp stated that the lead likely broke on its own.When asked what steps were taken to resolve the issue they stated that the x-ray showed the broken lead.The battery and proximal lead were removed, but the tip was not retrieved.The tip was not removed because it was still positioned in the sacral foramen and not easily extracted.There were no plans to remove the tip.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Continuation of d10: product id 978b128 lot# va2m3ge serial# implanted: (b)(6) 2022 explanted: (b)(6) 2024 product type lead medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Caller stated the md already filled form out and mailed back.Agent had colleague check to see if letter was ever received, but case was still open, no indication that letter was received, and no product returned.Caller stated md would not fill form out a second time as they were too busy.Caller was willing to provide information on the case, but did not answer individual questions with agent.Agent took down the following information.Cause of lead breaking is not clear.The caller made mention of lead possibly being broken inside of the patient prior to surgery.It was not clear if the context was in relation to risk of lead breaking in surgery.Caller indicated, per the operative note, that the lead "bundled up" and "twisted" in itself.It was noted that the lead was "deep below the bone plate and otherwise not creating issues" for the patient.The caller stated the lead tip that broke off was too deep within the patient to be safely retrieved.Weight at the time of surgery was 200 lb.The caller stated that at a post op appointment, the patient was told by a nurse practitioner that the "device was completely mri compatible." at this time, agent did review mri guidelines for presence of lead fragment only (caller stated a new ins was not placed when the old one was removed).Agent did fax mri guidelines to the caller.The cause for the explant was "pain and difficulty with the battery pack." the patient had a "bulge and redness" at the implant site and "tenderness with palpation." the tenderness did improve before surgery.

• 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: 18826339
• MDR Text Key: 336779573
• Report Number: 3004209178-2024-06177
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/20/2024

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: 11/28/2023
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 03/04/2024; 03/25/2024; 05/02/2024
• Supplement Dates FDA Received: 03/07/2024; 04/17/2024; 05/20/2024
• Date Device Manufactured: 06/09/2022
• 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
• Treatment: "SEE H11...."; "SEE H11...."; SEE H11...
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 91 KG