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

Model Number	37601
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d10 references: product id 3389s-40 lot# va0jsnp, implanted: (b)(6) 2014, product type lead product id 3708660, serial# (b)(6), implanted: (b)(6) 2014, product type extension section d information references the main component of the system.Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(6), ubd: 25-mar-2017, udi#: (b)(4) ; product id: 3708660, serial/lot #: (b)(6), ubd: 01-may-2018, udi#: (b)(4), 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from the healthcare provider (hcp), via the manufacturer¿s representative (rep), who reported pre-operative impedance issues prior to routine battery change at contact 8- monopolar was over 3,000 ohms.It was unknown what led to the issue.During surgery impedances were tested at 3v, but the issue wasn¿t resolved with the patient feeling a sensation at the lead and connector site.After the implant was changed impedances were taken with the same result of 8- monopolar greater than 3,000 ohms and bipolar pairs 8- 11- and 8- 10- over 4,000 ohms.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 20461935
• Report Number: 3004209178-2024-20420
• Device Sequence Number: 15383267
• Product Code: MHY
• UDI-Device Identifier: 00763000310332
• UDI-Public: 00763000310332
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2024

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: 07/28/2021
• Device Model Number: 37601
• Device Catalogue Number: 37601
• 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: 10/10/2024
• Initial Report FDA Received Date: 10/16/2024
• Date Device Manufactured: 01/31/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Male