MAUDE Adverse Event Report: ABBOTT MEDICAL KIT, EPG TRIAL, 2 PORT HEADER; EXTERNAL PULSE GENERATOR

Model Number	3599
Medical Device Problem Codes	Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Rash (2033); Post Operative Wound Infection (2446)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient's epg site had significant bleeding and leakage.The epg became corroded and was no longer functional.Patient developed a rash and possible infection below the epg site.As a result, the epg was removed to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.
Additional Manufacturer Narrative
Correction: section d4-model number should have been 3599 instead of 3032 in the previous report.Correction: section h6-medical device problem code should have been 1131-corroded instead of 2993 - adverse event without identified device or use problem in the previous report.It was reported the patient's epg site had significant bleeding and leakage.The epg became corroded and was no longer functional.Patient developed a rash and possible infection below the epg site.As a result, the epg was removed to address the issue.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 event could not be conclusively determined.
Additional Manufacturer Narrative
Further review of this event indicates the patient did not have a superficial infection but did develop a rash under the external device that did not require any intervention.Based on this information, this is event is not reportable and was reported in error.

• Brand Name: KIT, EPG TRIAL, 2 PORT HEADER
• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15491161
• Report Number: 1627487-2022-05172
• Device Sequence Number: 1905541
• Product Code: LGW
• UDI-Device Identifier: 05415067016560
• UDI-Public: 05415067016560
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 11/15/2023

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 Expiration Date: 08/31/2023
• Device Model Number: 3599
• Device Catalogue Number: 3599
• Device Lot Number: WMP118001
• 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: 09/06/2022
• Supplement Date Received by Manufacturer: 03/08/2023; 11/14/2023
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 03/16/2023; 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• 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: Male
• Patient Weight: 54 KG