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

Model Number	6660
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Pain Relief (2388)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patients ipg entered service app mode for an unknown reason, ipg was recovered, and therapy was restored.Patients ipg then enter service app mode again, several days later, again for an unknown reason.At this time the device is unable communicate with external devices.As a result, surgical intervention may be undertaken to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
Additional information indicates that surgical intervention was undertaken on (b)(6) 2025 wherein ipg was explanted and replaced to address the issue.
Additional Manufacturer Narrative
Correction e2 - health professional?- should be yes rather than no.
Additional Manufacturer Narrative
The reported event for no ipg communication was confirmed.It was determined the device was running the service application software.Since the device entered the service app state, and the patient didn't report an unrelated procedure, it is inconclusive as to what caused the service app condition.Since the device had a crc error, the ipg diagnostic logs could not be obtained and therefore a more thorough analysis could not be performed.

• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 22484944
• Report Number: 1627487-2025-03456
• Device Sequence Number: 8544656
• Product Code: MHY
• UDI-Device Identifier: 05415067020246
• UDI-Public: (01)05415067020246(10)T00005802(17)250426
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• 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
• Report Date (Section B): 10/21/2025

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: 04/26/2025
• Device Model Number: 6660
• Device Catalogue Number: 6660
• Device Lot Number: T00005802
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 07/09/2025; 10/07/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 07/30/2025; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• 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 Sex: Unknown