MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA SURESCAN; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number	978B128
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Retention (2119); Urinary Tract Infection (2120)
Date of Event	07/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date is approximate.Year is 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.
Event or Problem Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence it was reported that they were retaining big time.Patient said they were still getting utis and were on an antibiotic for it.Patient mentioned they went 3 months without a catheter because it was working and it wasn't working.Caller stated that the ins stopped working over the summer.Caller went on to say that they were sometimes still retaining urine which is causing utis.Caller stated that last week they were taken to the hospital and had another uti.Caller stated that they took an ultrasound of the patients bladder and it was empty , a few hours later they took another ultrasound and could see that the patient was retaining urine.Caller stated that the therapy was working intermittently.Agent asked if patient has had any falls or trauma to the area and patient said no.Patient stated they have made adjustments to the stimulation about 5-6 times , even sometimes with the help of th eir urologist.Patient confirmed they were feeling stimulation when they adjust it.Agent reviewed therapy information and general programming guidance with the patient.The patient was redirected to their healthcare provider to further address the issue.Caller stated that they are seeing their primary care hcp on friday to see if they can have their catheter removed.

• Brand Name: SURESCAN
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23375386
• Report Number: 2649622-2025-29921
• Device Sequence Number: 8870130
• Product Code: EZW
• UDI-Device Identifier: 00763000203726
• UDI-Public: (01)00763000203726(17)240303(10)VA2NG51
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2024
• Device Model Number: 978B128
• Device Catalogue Number: 978B128
• Device Lot Number: VA2NG51
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 10/23/2025
• Date Device Manufactured: 08/24/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR
• Patient Sex: Male