MAUDE Adverse Event Report: ABBOTT MEDICAL EPG KIT; EXTERNAL PULSE GENERATOR

Model Number	3599
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
Related manufacturer reference numbers: 3006705815-2023-01108; 3006705815-2023-01109.It was reported the patient had an infection at the epg and lead site.Cultures were obtained and results confirmed infection.As a result, the epg was removed and patient was placed on oral antibiotics to address the issue.
Additional Manufacturer Narrative
Correction: manufacturing reference number 1627487-2023-00802 should not have been reported as a medical device report (mdr) as the epg is not an implanted device.The location of the infection was located at the exist site of the leads.The epg would not have caused or contributed to the infection.

• Brand Name: EPG KIT
• Common Device Name: EXTERNAL PULSE GENERATOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16453310
• Report Number: 1627487-2023-00802
• Device Sequence Number: 5544308
• Product Code: LGW
• UDI-Device Identifier: 05415067016553
• UDI-Public: 05415067016553
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 05/31/2023

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 Model Number: 3599
• Device Catalogue Number: 3599
• Device Lot Number: WMP116770
• 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: 01/30/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• 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