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

Model Number 97800

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Erosion (1750)

Event Date 10/02/2023

Event Type  Injury  

Event Description

Information was received from an unknown source regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that patient notified clinic that surgical glue over incision site had come off.Her daughter had some surgical glue and reapplied to area.At clinic visit on (b)(6)2023, patient reports that the incision has "popped open", wound dehiscence two times, and the first time they could see the device.They reports closing the wound with surgical glue and butterfly bandages.Device was not visible at clinic visit. incision opened twice date of test: on (b)(6) 2023 | diagnostic type: examination specify results: device not visible; packed with wet to dry dressing date of test: on (b)(6) 2023. pocket packed with wet to dry dressing component: other component specify: device pocket action date: on (b)(6) 2023. explanted on (b)(6) 2023; replaced on (b)(6) 2024 component: entire system action date: on (b)(6) 2024.It was stated that this was probable related to incisional site/device tract, neurostimulator pocket. resolved without sequelae on (b)(6)2024.

Manufacturer Narrative

B3: event date is not known.Please see b5 for approximate date range, if applicable.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.

• 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: 18590905
• MDR Text Key: 333895515
• Report Number: 3004209178-2024-02425
• 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: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2024

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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 01/26/2024
• Date Device Manufactured: 07/24/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 41 KG