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

Model Number 1194

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Seroma (2069); Swelling/ Edema (4577)

Event Date 10/19/2023

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer reference number: 1627487-2023-05942 related manufacturer reference number: 1627487-2023-05943 related manufacturer reference number: 3006705815-2023-08199 related manufacturer reference number: 1627487-2023-05944 it was reported that the patient experienced swelling at the lead incision site.It was noted that the lead and ipg site both had fluid filled.Ct scan, ultrasound and blood test did not show any sign of infection.Additional blood test was done and the physician elected to explant the system due to risk of infection.As such, the entire system was explanted on (b)(6) 2023 to address the issue.

• Brand Name: CINCH LEAD ANCHOR
• Type of Device: 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: 18346567
• MDR Text Key: 330783939
• Report Number: 1627487-2023-05945
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024091
• UDI-Public: 05415067024091
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2024
• Device Model Number: 1194
• Device Lot Number: 8298962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other