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

Model Number 97800

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Burning Sensation (2146); Skin Inflammation/ Irritation (4545); Insufficient Information (4580)

Event Date 09/13/2023

Event Type  Injury  

Event Description

On 2023-oct-04, (b)(4) patlr (con): information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins) for urinary/bowel disfunction.It was reported that they are having a lot of problems with the "box" on their back (clarified referring to their implant).Pt reported their hcp told them that the implant was really inflamed around it.Pt stated now they are unable to get ahold of their hcp as no one answers the phone when pt calls.Pt reported they went to their hcp because they have been having a lot of problems and stated "we got to mashing around back there" and pt stated their hcp informed them that they are very inflamed around the implant area and it may need to come out.Pt also reported they are still burning when they are peeing.Ptstated this has been going on for about 3 weeks "or better" and later clarified it started probably in the middle of september when pt noticed it was really irritated.Pt stated they have been trying to contact their hcp but stated they get a message that no one is available to take their call.Reviewed their managing hcp's phone number on record and pt stated the number they have been calling is a different number.Reviewed role of patient services and redirected pt to their healthcare provider to further address the issue.Pt will continue trying to contact their physician with phone number agent reviewed.Additional information was received from the patient 2023-10-24.They reported that it just quit helping and that it will be taken out this friday after lunch time.

Manufacturer Narrative

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 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: 18150347
• MDR Text Key: 328301169
• Report Number: 3004209178-2023-21807
• 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: 11/16/2023

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: 03/14/2024
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/16/2023
• Date Device Manufactured: 09/22/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 71 KG