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

Model Number	37612
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Purulent Discharge (1812); Erythema (1840); Foreign Body Reaction (1868); Scar Tissue (2060); Ulcer (2274); Swelling/ Edema (4577)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with parkinson's disease experienced postoperative complications following the implantation of the im plantable neurostimulator.The patient exhibited signs of rejection, ulceration, and exposure of the lead at the site of the lead implant in the head, along with redness, swelling, and pus oozing from the site.Intermittent pus and scab formation were also noted.Additionally, there was exposure of the extension implanted behind the ear.The patient returned to the hospital for debridement, but the symptoms persisted.The doctor suggested the possibility of device removal due to the patient's rejection constitution, but the patient continued to use the device.The issue was resolved at the time of the report.
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name: lead; product id: neu_unknown_lead (serial: unknown); product type: 0200-lead.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
Continuation of d10: product id neu_unknown_lead, serial# unknown, implanted: (b)(6) 2017, product type lead.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 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: 21504183
• Report Number: 3004209178-2025-03849
• Device Sequence Number: 4591246
• Product Code: MHY
• UDI-Device Identifier: 00643169105492
• UDI-Public: 00643169105492
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• 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: 02/28/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/14/2025
• Date Device Manufactured: 09/15/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."; SEE H11...
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male