MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number	3023
Medical Device Problem Codes	Unintended Collision (1429); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Urinary Frequency / Polyuria (2275)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient asked if batteries could, "just stop working." patient reported they thought their battery stopped working because of symptoms they've been experiencing since about march.Patient reported symptoms of burning, sharp, stabbing pain at the lower vaginal area along with frequency at night.Patient mentioned they've been checked for bladder infections for the lastfew months.Agent asked patient if they ever tried turning their therapy off to see if it would affect the pain at all and patient said not since they developed the symptoms.Patient verbalized they were scared to turn therapy off for fear that it would make things worse.Patient said they had a couple seizures where they passed out and fell on the floor, and wondered if that could have caused damage.Agent reviewed it was possible, but reassuring that connection could be established and stimulation felt.Patient was unsure if impedance check was done at last appointment.Patient reported they went to managing healthcare provider's (hcp) office last week who was able to connect to ins, adjust settings, and confirm the battery life was still good.Patient denied ever getting any messages to indicate the battery was dead or dying.Patient confirmed they could feel the stimulation during the visit, and was instructed not to make any changes for 2 weeks.If the adjustment didn't help, patient was given a new medication, gemtesa, to start taking.Patient stated they don't want to go on the medication because they have leukemia and don't like taking drugs.Agent reviewed information and redirected patient to their healthcare provider to further address the issue.Of note, patient did mention they have a ct scan scheduled for next week.Additional information was received from the healthcare provider (hcp).It was reported that the patient has an upcoming appointment on (b)(6).
Additional Manufacturer Narrative
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
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20470201
• Report Number: 3004209178-2024-20481
• Device Sequence Number: 7245546
• Product Code: EZW
• UDI-Device Identifier: 00613994756558
• UDI-Public: 00613994756558
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 3023
• Device Catalogue Number: 3023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 10/17/2024
• Date Device Manufactured: 08/30/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female