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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Overheating of Device (1437); Insufficient Information (3190)

Patient Problems Pain (1994); Burning Sensation (2146); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2023

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim.It was reported that last week sometime they started having burning intermittently where the lead was at and tried turning it up and down, but was having difficulty."it wouldn't move for a minute." the doctor's office got patient in that day and was also having difficulty.The doctor was eventually able to program it and get it to stop but noted it was off.The patient did not realize therapy was off and did not know how it got turned off.The doctor wanted to leave the therapy off for 2 weeks to see if the burning would subside.The burning continued for a while even after it was off but has since completely stopped.Once the burning stopped patient knew the issue was connected to the interstim and the pain also stopped later that day.The patient had an x-ray taken on saturday and patient had not discussed the results with their doctor yet,but was able to access the results.Patient reported the x-ray results state: "a single lead is noted extended from the power pack to the left kidney/sacrum the lead appears intact but the proximal aspect of the lead appears to be unengaged with the first or first and second metallic portion of the power pack, suggesting slight retraction." patient reported no falls or traumas that could have caused lead retraction. the patient was redirected to their healthcare provider to further address the issue.Patient already has a scheduled appointment to follow up with managing physician.

Manufacturer Narrative

Date of event is estimated continuation of concomitant medical products: product id: 978b128, lot#: va2j580, 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.

• Brand Name: INTERSTIM II
• 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: 16404523
• MDR Text Key: 310267098
• Report Number: 3004209178-2023-02291
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000449711
• UDI-Public: 00763000449711
• 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
• Report Date: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2023
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2023
• Date Device Manufactured: 12/10/2021
• 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 Age: 47 YR
• Patient Sex: Female