MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ALTAVIVA; STIMULATOR, TIBIAL, ELECTRICAL, IMPLANTABLE, FOR URINARY INCONTINENCE

Model Number	P7850N
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Erythema (1840); Unspecified Infection (1930); Rash (2033); Impaired Healing (2378); Insufficient Information (4580)
Date of Event	04/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurosti mulator (ins) for urinary/bowel dysfunction.It was reported that the rep called in to report a potential infection or delayed wound healing.The rep found out about the issue a few hours ago during the 6-week post op visit with the physician assistant (pa).Pa stated that at the 2-week follow up incision check, allergic reaction to adhesive, the allergy was mentioned at that time by the patient (patient daughter acknowledged that they failed to report allergy on day of procedure).There was a distinct border/outline matching the adhesive dressing.The rep was not notified of this at the time.However, the pa reports that the incision site looks "different today compared to the 2-week follow-up." pa said they believed it could be "delayed wound healing due to age," as the patient also reported "bumping the incision site also the day after the procedure." they reported the patient is also on blood thinners.3 days of antibiotics were ordered and the pa plans to check in with the patient within a week.They will provide the rep with an update after.Additional information was received from a manufacturer representative (rep).The therapy developmental specialist (tds) reported that communication with the physician assistant (pa) on the day they were alerted, pa told me that they would reach out after the follow-up appointment if there was an issue/things worsened.The tds reached out this week and had a message into the provider with no response back at this time.The pa told them they prescribed oral antibiotics as a precaution.Pa reported that the site "appeared more red" at the 6 week post op visit.The tds did not know any of the patient's health information outside of what was initially shared.The tds had no additional information until they receive a response from the provider, they will also reach out to local sales rep to see if they had any communication.Additional information was received from a healthcare professional (hcp).The nurse stated that the patient had a cyst and an infection and was put on antibiotics.The nurse said the patient started with oral antibiotics that ended on (b)(6) 2026, and was then put in topical antibiotics- neosporin that ended on (b)(6) 2026.The patient¿s wound is healing appropriately now, and they are no longer on antibiotics.The nurse stated that they were not sure if the patient was on blood thinner and there is no information that the patient had an allergic reaction after the two weeks visit.The wound is healing appropriately with no concern at this moment.
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.
Event or Problem Description
Additional information was received from the patient.They reported that they had an infection with the incision, which involved rashes.The patient said they were finally healing up.
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: ALTAVIVA
• Common Device Name: STIMULATOR, TIBIAL, ELECTRICAL, IMPLANTABLE, FOR URINARY INCONTINENCE
• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 25113413
• Report Number: 3004209178-2026-07875
• Device Sequence Number: 15776118
• Product Code: QPT
• UDI-Device Identifier: 00763000936433
• UDI-Public: (01)00763000936433(17)270328(20)01
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P240011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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 Model Number: P7850N
• Device Catalogue Number: P7850N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 05/12/2026
• Date Device Manufactured: 10/01/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female