MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. Percept; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI

Model Number	B35300
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that information was received from a patient regarding an external device.The reason for call was that the caller reports that they are having trouble with the recharger.The caller indicates that the connection keeps breaking between the recharger and ins all the time and it takes forever to charge the implanted neurostimulator.The issue has been going on for "quite a while" and it seems to be getting worse.They have not had any falls, trauma, or significant changes to weight.Helped caller use the recharger without the drape and after repositions they were able to see excellent connection and go from 90% to 100% while on the call.Caller noted that the harness is too big for them and it feels like it is strangling them.A smaller drape was sent.The caller will continue to monitor recharging.The caller was not able to find the serial number of the recharger on the handset and agent did not want them to pull it away to get the serial number off the back.Additional update was received from patient stating the replacement device was better but still it was too long and they just held it in place while being laid down.
Additional Manufacturer Narrative
Continuation of d10: product id: fp6000s, lot# serial#: unknown, implanted: on (b)(6) 2025, product id: neu_rechar ger_acc, lot# serial#: unknown, product type: recharger.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: Percept
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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 ; +1(763)526-5677
• MDR Report Key: 50785098
• Report Number: 3004209178-2026-15636
• Device Sequence Number: 18523020
• Product Code: PJS
• UDI-Device Identifier: 00763000564346
• UDI-Public: (01)00763000564346(17)270528
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: B35300
• Device Catalogue Number: B35300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 06/04/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "See H11."
• Patient Sex: Female