MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM¿ 5 IMPLANTABLE PULSE GENERATOR, HEADER M; SCS IPG

Model Number	3661
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Pain Relief (2388)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported that the patient had an unrelated surgery wherein the device was not placed in surgery mode.Subsequently, the patient had trouble connecting to the ipg.Troubleshooting was attempted but the issue was not resolved.As a result, surgical intervention may take place at a later date to address the issue.
Event or Problem Description
Additional information indicates surgical intervention took place on (b)(6) 2024, wherein the ipg was explanted and replaced to address the issue.
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.

• Brand Name: PROCLAIM¿ 5 IMPLANTABLE PULSE GENERATOR, HEADER M
• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 20777876
• Report Number: 1627487-2024-12221
• Device Sequence Number: 5051672
• Product Code: LGW
• UDI-Device Identifier: 05415067020208
• UDI-Public: (01)05415067020208(10)8078355(17)230618
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 01/05/2025

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: 06/18/2023
• Device Model Number: 3661
• Device Catalogue Number: 3661
• Device Lot Number: 8078355
• 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: 11/04/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 01/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2021
• 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: Female
• Patient Weight: 73 KG