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	High impedance (1291)
Health Effect - Clinical Codes	Movement Disorder (4412); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: event date is estimated.
Event or Problem Description
It was reported that the patient's system was auto reducing due to high impedances.Surgical intervention was undertaken and the ipg, lead and extension were explanted and replaced.
Additional Manufacturer Narrative
The report of ¿high impedance¿ and ¿auto-reducing¿ was not confirmed the ipg had minor tooling marks on the can as a result of the explant procedure, the device communicated with all lab utilities and passed all functional tests on the ate (automated test equipment), which specifically tests for header integrity through a process of 55 iterations of lead impedance testing and calculation.The therapy delivery log showed many program status errors which would indicate that high impedances were experienced and auto-reducing of the output stimulation occurred.The associated lead extension that was returned with the ipg had all wires fractured which would be the cause of this.

• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 21052206
• Report Number: 3006705815-2025-00003
• Device Sequence Number: 7948038
• Product Code: MHY
• UDI-Device Identifier: 05415067030016
• UDI-Public: (01)05415067030016(10)A000140483(17)250402
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2024
• 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): 03/04/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2025
• Device Model Number: 6660
• Device Catalogue Number: 6660
• Device Lot Number: A000140483
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 01/01/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 54 KG