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

Model Number	37602
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Discomfort (2330); Shaking/Tremors (2515); Electric Shock (2554)
Type of Reportable Event	Malfunction
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 consumer.Reported, the patient was getting an unfamiliar icon on the device.They needed an explanation for.The patient replaced the batteries to resolve the issue.
Event or Problem Description
The patient (pt) reported that their dbs settings were a lot higher in the beginning and patient had them lowered because they felt like they were getting electrocuted constantly on the higher setting.Pt said they have dbs for tremor and they said that with a lower setting their tremor wasn't as controller but they were fine with that because they didn't have the discomfort at a lower setting.Patient said what's a little bit of shaking when they have tremor and before getting the dbs their tremor was a lot worse so the dbs surgeon did a good job.The patient said they were looking for a new managing healthcare provider (hcp)  because they wanted to find any hcp they could work with regarding settings and said the hcp had just kind of decided on the setting they wanted the patient to be on and patient wanted more input.Ps emailed pt hcp listings and reviewed role of manufacturer representative (rep).
Additional Manufacturer Narrative
B3: event date is not known.Please see b5 for approximate date range, if applicable.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: ACTIVA
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19108094
• Report Number: 3004209178-2024-09111
• Device Sequence Number: 7428197
• Product Code: PJS
• UDI-Device Identifier: 00613994761057
• UDI-Public: 00613994761057
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

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: 02/28/2018
• Device Model Number: 37602
• Device Catalogue Number: 37602
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 05/21/2024
• Date Device Manufactured: 09/06/2016
• 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
• Patient Sex: Female
• Patient Weight: 52 KG