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

Model Number 1192

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

Patient Problem Implant Pain (4561)

Event Date 04/05/2023

Event Type  Injury  

Manufacturer Narrative

Date of the event is estimated.Additional components potentially involved in the event include: common device name: scs anchor, model: 1192, udi: (b)(4), serial: na, batch: 4935446.

Event Description

The patient reported discomfort at the anchor site.In turn, surgical intervention may occur to address the issues.The investigation did not determine which anchor was causing discomfort.

Event Description

Per the additional information received, the device did not contribute to reported issue, there is no device malfunction.Hence, this device no longer meets the reportability criteria.

Manufacturer Narrative

Correction b5: the physician does not believe the anchor is not contributing to the pain patient is experiencing.As such, no intervention was taken on the anchors.There is no device malfunction.Hence, this device no longer meets the reportability criteria.

• Brand Name: SWIFT-LOCK 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: 16811323
• MDR Text Key: 313964147
• Report Number: 1627487-2023-01834
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734400671
• UDI-Public: 05414734400671
• 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: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 4823445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2014
• 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 ANCHOR; SCS IPG; SCS LEAD (2)
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 82 KG