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

Model Number	37601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(4), ubd: 23-sep-2023, udi#: (b)(4); product id: 3389s-40, serial/lot #: (b)(4), ubd: 23-sep-2023, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 11-may-2025, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 11-may-2025, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient had an infection at the battery site in the chest and at the extension site behind the ear after surgery.The ins, extensions, and leads were explanted and were not to be re-implanted.The patient was observing at home.

• 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
• MDR Report Key: 12458033
• Report Number: 3004209178-2021-13684
• Device Sequence Number: 19777977
• Product Code: MHY
• UDI-Device Identifier: 00763000384326
• UDI-Public: 00763000384326
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2021

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: 04/14/2022
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR