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

Model Number	6660
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter phone number (b)(6).Date of event is estimated.
Event or Problem Description
It was reported that diagnostics indicated the elective replacement indicator (eri) triggered earlier than intended.The device had the appropriate level of battery voltage to provide therapy.The device was explanted and replaced.
Additional Manufacturer Narrative
Corrected data d10 - concomitant medical products and therapy dates it was reported to abbott a patient¿s infinity 5 ipg was explanted and replaced with a liberta ipg.The infinity 5 ipg had issued the elective replacement indicator.Pre-op impedance checks showed all measurements were within normal limits.After the new ipg was connected 3 directional contact showed high impedances that could not be resolved.Despite the impedance issue, effective stimulation was established using the previous parameters.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.

• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 21877648
• Report Number: 1627487-2025-01929
• Device Sequence Number: 8769124
• Product Code: MHY
• UDI-Device Identifier: 05415067020246
• UDI-Public: (01)05415067020246(10)T00005398(17)250328
• 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: 2023
• Device Explanted Year: 2025
• 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): 04/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2025
• Device Model Number: 6660
• Device Catalogue Number: 6660
• Device Lot Number: T00005398
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DBS EXTENSION X2; SCS EXTENSION
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown