MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR; DBS IPG

Model Number	6663
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Septic Shock (2068)
Date of Event	01/01/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient expired.There is no known allegation from a healthcare professional that suggests the death was related to the device.It was reported that the cause of death was septic shock.
Additional Manufacturer Narrative
A patient death, was reported to abbott.Event details describe health issues unrelated to the implanted system.There is no known ,allegation from a healthcare professional ,that suggests the death was related to the device.It was reported, that the cause of death was septic shock.Additionally, the device history record of the device was reviewed to confirm, that all manufacturing steps were completed.And there were no non-conformances noted, that could have contributed to this issue.

• Brand Name: INFINITY¿ 7 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18551096
• Report Number: 1627487-2024-00357
• Device Sequence Number: 18074529
• Product Code: MHY
• UDI-Device Identifier: 05415067020277
• UDI-Public: 05415067020277
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 07/16/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2025
• Device Model Number: 6663
• Device Lot Number: T00005395
• 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: 01/02/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male