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 Fever (1858); Pain (1994); Urinary Retention (2119); Vomiting (2144); Chills (2191); Shaking/Tremors (2515)

Event Date 01/30/2023

Event Type  Injury  

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.

Event Description

Information was received from a patient and friend/family member about patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported by that they think the device stopped working.They said on monday the patient voided at 6am and normally goes every couple of hours because they drink a lot of water but around 11am, said the patient started shaking and was freezing, as well as earlier that day was experiencing back pain.They said the patient had a fever of 103 and also started vomitting.They said patient is a cardiac patient so they thought it was related to this and they took the patient to the er and found out the patient had a full bladder and hadn't emptied in 8 hours.They said patient did not have the urge to go so they put a catheter in and that on the way to the er, the shaking and vomitting had stopped and when they got to the er, they took xrays, ekg and other tests and found nothing wrong.They said they just have a sense the ins wasn't working because it had been working f ine since implant and said the patient had no problems, was voiding normally and could feel the urge to go until monday.They said maybe the ins caused patient's reaction, but they are still unsure.The reason for call was they said they called sunmed yesterday because they thought they lost the programmer but said they found it, but lost the charging cord.The patient and caller was redirected to purchase a usb-c cord and call ps back if they need assistance making any adjustments.

• 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: 16292026
• MDR Text Key: 308725497
• Report Number: 3004209178-2023-01560
• 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: 02/03/2023

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: 12/14/2023
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/03/2023
• Date Device Manufactured: 06/27/2022
• 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): Other
• Patient Age: 69 YR
• Patient Sex: Male