MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number	6662
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient's ipg lost communication with all external devices following a fall.Troubleshooting was unable to resolve the issue.Surgical intervention may be pending to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.E1 - reporter phone number: (b)(6).

• Brand Name: INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR
• Common Device Name: SCS 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: 24736942
• Report Number: 1627487-2026-01256
• Device Sequence Number: 9242583
• Product Code: MHY
• UDI-Device Identifier: 05415067020260
• UDI-Public: (01)05415067020260(10)8050512(17)230511
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/11/2023
• Device Model Number: 6662
• Device Catalogue Number: 6662
• Device Lot Number: 8050512
• 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: 03/06/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2021
• 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