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

Model Number 3058

Device Problems Break (1069); Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Component Missing (2306)

Patient Problems Neuropathy (1983); Pain (1994); Urinary Retention (2119); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2022

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 978b128, lot# va2j58w, implanted: (b)(6) 2022, product type: lead.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(4), ubd: 02-aug-2023, udi#: (b)(4).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 (pt) with an implanted neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that the pt's interstim became annoying on (b)(6) 2022 and they turned it off.It was set on program 4 at 0.3.The interstim became unbearable on (b)(6) and pt turned it off at 5:00 am and left it off until (b)(6).Pt saw their doctor on (b)(6).The doctor scoped the pt and it appeared their bladder is "very worse for the wear." pt turned the interstim back on (b)(6) but could not find any programs or intensity that felt right.Pt turned it back off.Pt has never felt the appropriate sensations in the saddle area.Pt was not sure what the various settings even address.Pt thought they were being treated for retention.They were hanging onto 600cc when they came to medtronic, but stated "your pas have mentioned i had an overactive bladder.I think that is in error." pt mentioned most tools come with an operator's manual, but not this.Pt's sensations are generally to the right cheek, down the back of the leg, and to their foot.They also get pain directly from the device.Looking back over their diaries, they noted nothing has changed much since the pre-studies.Program 5 seemed favorable for a while but the medtronic tech moved pt to program 4.It seemed okay for a while until they had to turn it off because of pain.Results, while it was off, were not much different than when it was on.Pt thinks most of their gains have come from frequent cathing (4x day) and giving their bladder a rest.Pt mentioned this month of hell came along so they don't where to go from here.In an update, pt noted this has now continued through (b)(6) 2022.The only tolerable setting is 4 at 0.4 or lower.Anything else makes their right buttock quiver, produces shooting pain down the back of their right leg, causes neuropathy in their right foot, and a throbbing right big toe.Pt noted that they think the lead has broken, migrated, or was incorrect from the beginning.Troubleshooting was not able to be done as patient emailed in their concerns.

Manufacturer Narrative

Continuation of d10: product id: 978b128, lot#: va2j58w, implanted: on (b)(6) 2022, 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 was received from the patient.They reported that the issue has not yet been resolved, and no one was located to do it.

• 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: 15201313
• MDR Text Key: 305337877
• Report Number: 3004209178-2022-10119
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000449711
• UDI-Public: 00763000449711
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2023
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 10/03/2022
• Supplement Dates FDA Received: 10/27/2022
• Date Device Manufactured: 11/02/2021
• 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
• Treatment: "SEE H10."
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 80 KG