MAUDE Adverse Event Report: St. Jude Medical - Neuromodulation (Puerto Rico, LLC) Infinity¿ 7 Implantable Pulse Generator; DBS IPG

Model Number	6662
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported that the patient was unable to place their system into mri mode.Diagnostics revealed low impedances on the right lead.As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the ipg was explanted and replaced to address the issue.

• Brand Name: Infinity¿ 7 Implantable Pulse Generator
• Common Device Name: DBS IPG
• Manufacturer (Section D): St. Jude Medical - Neuromodulation (Puerto Rico, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): St. Jude Medical - Neuromodulation (Puerto Rico, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: sara speyerer ; 6901 preston road; plano, TX 75024 ; +1(972)309-8000
• MDR Report Key: 50860398
• Report Number: 3006705815-2026-05957
• Device Sequence Number: 9498388
• Product Code: MHY
• UDI-Device Identifier: 05415067030023
• UDI-Public: (01)05415067030023(10)A000153261(17)260204
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 02/04/2026
• Device Model Number: 6662
• Device Catalogue Number: 6662
• Device Lot Number: A000153261
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2024
• 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 Cover (x2); DBS Extension (x2); DBS LEAD (x2)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 102 LB