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

Model Number	6660
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: event date is estimated.
Event or Problem Description
It was reported that the patient underwent surgical intervention on (b)(6) 2025 in which their ipgs were explanted and replaced for an unknown reason.
Additional Manufacturer Narrative
Correction b5: additional information indicates the ipg meets or exceeds 75% of its expected longevity.There is no device malfunction; therefore, this device is no longer considered reportable.
Event or Problem Description
Additional information indicates the ipg meets or exceeds 75% of its expected longevity.There is no device malfunction; therefore, this device is no longer considered reportable.

• 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: 23936739
• Report Number: 1627487-2025-06447
• Device Sequence Number: 9626957
• Product Code: MHY
• UDI-Device Identifier: 05415067020246
• UDI-Public: (01)05415067020246(10)T00000918(17)240127
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: 01/27/2024
• Device Model Number: 6660
• Device Catalogue Number: 6660
• Device Lot Number: T00000918
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2022
• 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 BUR HOLE COVER; DBS BUR HOLE COVER.; DBS EXTENSION (X2).; DBS LEAD.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 66 KG