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 Problem Post Operative Wound Infection (2446)

Event Date 08/04/2022

Event Type  Injury  

Event Description

Related manufacturer reference numbers: 3006705815-2022-16836; 1627487-2022-05079.It was reported the patient developed an infection at the lead and anchor site.As a result, surgical intervention occurred wherein the scs system was explanted to address the issue, patient was placed on oral antibiotics.

Manufacturer Narrative

Date of event is estimated.

Manufacturer Narrative

An event of infection was reported to abbott.It was conveyed that the infection originates at the lead(s) and anchor site(s).The entire system was explanted; however, no explanted products were returned for analysis.Oral antibiotics were administered to the patient to address the issue.As a result, a device history record was performed to review and confirm the sterility of the lead(s) and anchor(s).Based on the documents reviewed, the source of the infection remains unknown.

• 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15442544
• MDR Text Key: 300117034
• Report Number: 1627487-2022-05080
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024091
• UDI-Public: 05415067024091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2022
• Device Model Number: 1194
• Device Catalogue Number: 1194
• Device Lot Number: 7592711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• 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
• Treatment: SCS IPG
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 91 KG