MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR; DBS IPG

Model Number	6660
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anxiety (2328); Suicidal Ideation (4429)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter phone number (b)(6).B3-date of event is estimated.
Event or Problem Description
It was reported that patient experienced anxiety and committed suicide after a dbs implant.Patient did receive adequate psychiatric care and specific medications.
Event or Problem Description
Additional information received identified that the suicide was unrelated to the device.
Additional Manufacturer Narrative
Correction: based on information previously received that the reported event was not related to the system, this event is no longer considered reportable.Investigation conclusion: a patient death was reported to abbott.Event details describe suicide unrelated to the implanted system.Additionally, no system complaints were reported nor were implanted products returned for analysis.All event information pertaining to this device has been reviewed and no product investigation is necessary at this time as the circumstances of the event have not been attributed to the implanted system.

• Brand Name: INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR
• Common Device Name: DBS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: sara speyerer ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 21381778
• Report Number: 1627487-2025-00700
• Device Sequence Number: 20901168
• Product Code: MHY
• UDI-Device Identifier: 05415067020246
• UDI-Public: (01)05415067020246(10)T00003456(17)240418
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2025

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: 04/18/2024
• Device Model Number: 6660
• Device Catalogue Number: 6660
• Device Lot Number: T00003456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 05/08/2025; 10/06/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 05/27/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2022
• 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: DBS EXTENSION X2; DBS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 53 KG