MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number	B35200
Medical Device Problem Codes	Premature Discharge of Battery (1057); High impedance (1291); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Mdt rep reported, that two months ago.The patient was told by their provider, that they had six months left before eos (end of service).Rep was notified yesterday, that the patient's implantable neurostimulator (ins) had depleted almost completely.And was requiring replacement.Patient did not change settings, as they do not have the capability.Additionally, clinician indicated always having an impedance issue with contact 7.Today, the percept pc showed, all contacts on right lead were 10k ohms, when impedance test was done at 1% battery charge.Troubleshooting was performed.And percept rc replaced.Impedance test run and impedance issue noted, at contact 7 with all other contacts.Caller did state, patient did not use contact 7 in their programming.Rep was curious if the low battery charge of 1% could have contributed to impedance issues at all contacts on the right side, prior to replacing.The rep and managing provider were also curious if the rapid battery depletion was related to the presence of the pocket adaptor.The patient services agent consulted with their colleague and determined, the pocket adaptor does not significantly affect the longevity of the battery.Also, the impedance issue was likely, not related to the low charge.Agent suggested, rep send in session logs/reports for further analysis.No symptoms were reported.
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.
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 received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the impedance issue was known on contact 7.After running impedance measurements all contacts on the right lead were out of range.The device was at eos with 1% battery (which according to the hcp was premature as the final session report said it had 6 months beforeeri).After connecting to a new neurostimulator all impedances except contact 7 were normal.The rep had the hcp do some pocket maneuvers while they ran impedance measurements and everything was stable.

• Brand Name: PERCEPT
• Common Device Name: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 20600158
• Report Number: 3004209178-2024-21451
• Device Sequence Number: 18342205
• Product Code: MRU
• UDI-Device Identifier: 00763000253363
• UDI-Public: 00763000253363
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: H020007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: 06/14/2022
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 11/13/2024
• Date Device Manufactured: 06/16/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male