MAUDE Adverse Event Report: ABBOTT MEDICAL CINCH LEAD ANCHOR; SCS ANCHOR

Model Number	1194
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	08/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced an infection at the ipg site that spread to lead site.As a result, surgical intervention was undertaken on (b)(6) 2024 wherein the entire system was explanted to address the issue.The patient was administered iv antibiotics and has iv antibiotic infusions every week for 6 weeks to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.
Additional Manufacturer Narrative
A patient experienced an infection at the ipg, and lead site(s) was reported to abbott.Surgical intervention was undertaken wherein the entire system was explanted.The patient was administered iv antibiotics and has iv antibiotic infusions to address the issue.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.The results of the investigation are inconclusive based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• Brand Name: CINCH LEAD ANCHOR
• Common Device Name: SCS 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: 20050424
• Report Number: 1627487-2024-10602
• Device Sequence Number: 15442618
• Product Code: GZB
• UDI-Device Identifier: 05415067024091
• UDI-Public: (01)05415067024091(10)4197852(17)151228
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K081208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 11/13/2024

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: 12/28/2015
• Device Model Number: 1194
• Device Catalogue Number: 1194
• Device Lot Number: 4197852
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2013
• 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: 104 KG