MAUDE Adverse Event Report: St. Jude Medical - Neuromodulation (Puerto Rico, LLC) Infinity¿ 7 Implantable Pulse Generator; Stimulator, Electrical, Implanted, For Parkinsonian Tremor

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	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced discomfort at the ipg site.As a result, surgical intervention was undertaken on 10jul2026 wherein the ipg was explanted and replaced to address the issue.

• Brand Name: Infinity¿ 7 Implantable Pulse Generator
• Common Device Name: Stimulator, Electrical, Implanted, For Parkinsonian Tremor
• 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: 50124387
• Report Number: 3006705815-2026-04871
• Device Sequence Number: 10560956
• Product Code: MHY
• UDI-Device Identifier: 05415067030023
• UDI-Public: (01)05415067030023(10)A000157306(17)260428
• 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,Followup
• Report Date (Section B): 08/11/2026

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: 04/28/2026
• Device Model Number: 6662
• Device Catalogue Number: 6662
• Device Lot Number: A000157306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Supplement Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2024
• 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 CAP; DBS BURR HOLE CAP; DBS EXTENSION (x2); DBS LEAD; DBS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 210 LB