MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. Percept; Stimulator, Electrical, Implanted, For Parkinsonian Tremor

Model Number	B35300
Medical Device Problem Codes	Intermittent Continuity (1121); Failure to Deliver Energy (1211); Failure to Interrogate (1332); Battery Problem (2885); Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	Abdominal Pain (1685); Dysphasia (2195); Shaking/Tremors (2515); Insufficient Information (4580)
Date of Event	09/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient's therapy is off as of this morning and they don't know how to turn it back on.Manufacturer representative (rep) said the patient went to the hospital over the weekend and whenever the patient goes to the hospital, the therapy turns off.Agent asked if the hospital stay was related to the device/therapy and representative said no, it was unrelated.Representative tried to connect to the dbs therapy app on the handset but was getting the 'not found' message.Representative scanned the code on the back of the communicator and was able to connect.Representative then saw a service code 634.The issue was not resolved through troubleshooting.Agent reviewed code and advised the caller to charge the stimulator, as they are not getting therapy due to the implantable neurostimulator (ins) being low.Patient rep reported that patient can barely talk, that he can't eat, trembling and he also has abdominal pain since last friday.Caller thinks the implant is depleted as it has for the last 4 times in the last 6 months.Handset was able to connect to the communicator after a reset, however, it go no device response.Technical services(ts) troubleshoot with the recharger and couldn't ever get it to connect after multiple resets and confirming information on the handset.It was eventually discovered the recharger was not compatible with patient's current implant.Caller to get the appropriate recharger to charge patient's implant.Additional information was received from a manufacturer's representative repeating previously reported information.Patient was in the hospital and the patient thought the stimulator therapy was off because the ins was not charged.Caller said that they are having issues connecting to the ins with tablet, patient handset, and recharger.Agent mentioned that when they place the recharger over the ins, they got an error: 1713.During the call, it was discovered that the recharger was the incorrect version.
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: Percept
• Common Device Name: Stimulator, Electrical, Implanted, For Parkinsonian Tremor
• 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: 50882991
• Report Number: 3004209178-2026-16224
• Device Sequence Number: 13202110
• Product Code: MHY
• UDI-Device Identifier: 00763000564346
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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?: 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 07/12/2025
• 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...."
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male