MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR; DBS IPG

Model Number	6660
Medical Device Problem Codes	Battery Problem (2885); Wireless Communication Problem (3283)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Pain Relief (2388); Movement Disorder (4412); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.E1: reporter phone number: (b)(6).
Event or Problem Description
It was reported the patient's ipg had connection issues with external devices.In turn, surgical intervention may be pending to address this situation.
Event or Problem Description
Additional information was obtained wherein the ipg was explanted and replaced to address the issue.
Event or Problem Description
Additional information was obtained that effective therapy was restored.
Additional Manufacturer Narrative
The reported observation of connection difficulties was confirmed.The root cause of the reported observation was due to a fractured bluetooth (ble) antenna within the header assembly.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 necessary portions of ate testing passed.The ate tests perform all testing through the ipg¿s ble circuitry at a distance of approximately 1 foot.The device exhibited normal communication throughout testing which included testing the receiver signal strength (rssi) value of the bluetooth communication between the ipg and the ate ble.The rssi was also verified using a clinician programmer and a patient controller and normal values were measured.The device exhibited normal characteristics throughout analysis.An x-ray of the device¿s header assembly found the ble antenna was fractured at the can connection within the header assembly and a possible second fracture at the top of the antenna.Both fractures appear to be at the weld site.Actions have been taken to prevent reoccurrence.

• Brand Name: INFINITY¿ 5 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: 21998463
• Report Number: 1627487-2025-02276
• Device Sequence Number: 9447044
• Product Code: MHY
• UDI-Device Identifier: 05415067020246
• UDI-Public: (01)05415067020246(10)T00005398(17)250328
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/23/2025

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 Expiration Date: 03/28/2025
• Device Model Number: 6660
• Device Catalogue Number: 6660
• Device Lot Number: T00005398
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 06/12/2025; 07/24/2025; 11/20/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 07/08/2025; 08/14/2025; 11/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female