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); No Device Output (1435); Battery Problem (2885); Electromagnetic Compatibility Problem (2927)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2023

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor, urinary dysfunction,/sacral nerve stim.It was reported that they are going to get their current implant system replaced with an mri compatible implant system in the beginning of december.Patient reported when they "deactivated" their current implanted system last thursday, they couldn't "reactivate it" and got an error message.Patient clarified when they "checked it a couple weeks ago" it said their implant battery was low and patient stated that was great as they are planning to get the new implanted system at the beginning of december anyways.Patient reported they had "another inspire sleep apnea" device implanted and when they went to activate that they turned off their interstim device to make sure there was not any interference and when they tried to start their interstim back up again/turn therapy back on they got an error message that they think said "njy444677h therapy is off", or that therapy is either off or "is complete".Patient stated they did not have exact error message in front of them as patient stated they did not have external equipment with them at the time of the call as patient stated they are currently in ca.Agent tried to clarify if pa tient saw eos message and patient stated they did not remember seeing that message.Patient stated their hcp advised patient contact a rep due to this to see if they can "get it working again".Patient stated they want to meet with a rep when back home in austin.Agent did not ask about the circumstances that led to the reported issue.Sent email to mdt rep per patient's request to contact patient.

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 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: 18139268
• MDR Text Key: 328150961
• Report Number: 3004209178-2023-21227
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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: Other
• Type of Report: Initial
• Report Date: 11/15/2023

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: 09/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 11/15/2023
• Date Device Manufactured: 04/08/2019
• 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: 64 YR
• Patient Sex: Male