MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR; DBS IPG

Model Number	6660
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Movement Disorder (4412)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient experienced infection and wound issues at the lead site.As a result, the patient underwent a lead washout procedure on (b)(6) 2025 to address the issue.During the procedure, the device was not placed into surgery mode and the ipg became unable to communicate with external devices.Troubleshooting has been able to resolve the issue and the ipg is operable.The infection and wound issue have since resolved.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Additional Manufacturer Narrative
Correction: h6 - health effect - clinical code should have been 4412 - movement disorder instead of 2388 - inadequate pain relief.

• Brand Name: INFINITY¿ 5 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 ; 9723098000
• MDR Report Key: 23477167
• Report Number: 3006705815-2025-19148
• Device Sequence Number: 21381382
• Product Code: MHY
• UDI-Device Identifier: 05415067030016
• UDI-Public: (01)05415067030016(10)A000168913(17)270128
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,Followup
• Report Date (Section B): 12/18/2025

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 Model Number: 6660
• Device Catalogue Number: 6660
• Device Lot Number: A000168913
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 11/12/2025; 12/18/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/05/2025; 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2025
• 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 COVER.; DBS EXTENSION.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 108 KG