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

Model Number	6662
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported observation of the ipg battery being at eri was confirmed.The ipg logs showed first eri was timestamped on 10/11/2025.First eri is logged when the device is queried and the battery voltage is at or below 2.7v +/- 30mv.The ipg had not logged eol.The root cause of the reported observation was due to a normally depleted battery.The device was subjected to a functional test on automated test equipment (ate).This tester verifies the electrical performance of the control/communication circuitry, and output signal integrity.All portions of ate testing passed.This test specifically measures the stimulation output parameters and any cross-chamber leakage currents between stimulation channels, no anomalies were flagged.It was also noted no voltage multiplier overhead (vmo) errors (typically caused by lead impedance issues) were logged other than when a program change was made or the device was placed in surgery mode.This suggested there were no stimulation irregularities that would result in pain at the ipg site.The estimated longevity would have been 2.25 years +/-.25-year per ¿ (b)(4), assuming 1000-ohm program impedances, for device model 6662.The total stimulation on time was 2.4 years, suggesting the device had normal battery depletion at the time of the observation.
Additional Manufacturer Narrative
Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that the patient experienced pain at the ipg site.As a result, surgical intervention was undertaken on (b)(6) 2025 wherein the ipg was explanted and replaced.

• 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: sara speyerer ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 23493648
• Report Number: 1627487-2025-05469
• Device Sequence Number: 18368733
• Product Code: MHY
• UDI-Device Identifier: 05415067020260
• UDI-Public: (01)05415067020260(10)T00005327(17)250222
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: 02/22/2025
• Device Model Number: 6662
• Device Catalogue Number: 6662
• Device Lot Number: T00005327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2023
• 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 BURR HOLE CAP; DBS BURR HOLE CAP; DBS EXTENSION (X2); DBS LEAD; DBS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 88 KG