MAUDE Adverse Event Report: ABBOTT MEDICAL CINCH LEAD ANCHOR

Model Number	1194
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Fever (1858); Chills (2191); Post Operative Wound Infection (2446); Swelling/ Edema (4577)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced an infection at ipg site and lead sites.Patient was treated with antibiotics for three weeks.Patient was asymptomatic but the drainage persisted.As a result, surgical intervention was undertaken wherein the entire system was explanted to address the system.
Additional Manufacturer Narrative
B3-date of event is estimated.A patient experienced an infection at ipg site and lead sites was reported to abbott.The patient was treated with antibiotics.Patient was asymptomatic but the drainage persisted.Surgical intervention was undertaken wherein the entire system was explanted to address the system.As a result, a device history record was performed to review and confirm the sterility of devices.Based on the documents reviewed, the source of the infection remains unknown.

• Brand Name: CINCH LEAD ANCHOR
• Common Device Name: ANCHOR
• 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: 20186364
• Report Number: 1627487-2024-10869
• Device Sequence Number: 7002638
• Product Code: GZB
• UDI-Device Identifier: 05415067024091
• UDI-Public: (01)05415067024091(10)10059727(17)251031
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2024

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: 10/31/2025
• Device Model Number: 1194
• Device Catalogue Number: 1194
• Device Lot Number: 10059727
• 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: 08/21/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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: Female
• Patient Weight: 68 KG