MAUDE Adverse Event Report: ABBOTT MEDICAL SWIFT-LOCK ANCHOR; LEAD ANCHOR

Model Number 1192

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

Patient Problem Implant Pain (4561)

Event Date 04/25/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Manufacturer report number: 1627487-2022-02798.It was reported that the patient was experiencing pain at the anchor site.Surgical intervention may occur to address the issue.

Manufacturer Narrative

Upon review, the issue should not have been submitted as a medical device report (mdr) as there is no indication the device caused or contributed to the issue.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: LEAD 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: 14421567
• MDR Text Key: 291875488
• Report Number: 1627487-2022-02799
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092371
• 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: 06/09/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2019
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 6052902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/17/2022
• Supplement Dates Manufacturer Received: 05/20/2022
• Supplement Dates FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2017
• 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: IPG; LEAD (X2)
• Patient Outcome(s): Other
• Patient Sex: Female