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

Model Number 97800

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Wound Dehiscence (1154)

Event Date 04/18/2024

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that they had their husband look at the incision site where the device was implanted last night ((b)(6) 2024), and they noted the steri-strip had already fallen off a couple of days ago, but last night, when their husband looked at the site, they could see the ins through the incision.The patient stated they couldn't see the incision site themselves because it was on their booty; however, they stated their spouse said it didn't look infected.They had a picture of it where you could see it but when they moved, you couldn't see the ins.The patient stated they called their health care provider (hcp) office first thing this morning and spoke with someone who said they would "send a message" about it, but they still hadn't heard from the hcp, so they thought they'd call patient services instead because they didn't know what to do and they didn't have the number of the local medtronic representative (rep) to call.Patient services reviewed the role of the rep with the patient and redirected the patient to continue trying to contact their health care provider (hcp).Patient services also sent an email to the mdt rep to alert them of the situation.  patient services again redirected the patient to follow up with their hcp.Patient stated they would.Documented the reported event.No further action was taken by patient services.

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed valid.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.

• 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: 19202339
• MDR Text Key: 341788147
• Report Number: 3004209178-2024-09924
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• 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
• Date Manufacturer Received: 04/25/2024
• Date Device Manufactured: 01/22/2024
• 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: 56 YR
• Patient Sex: Female