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 Wound Dehiscence (1154)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.The unique device identifier (udi #) is unknown because the lot and part number were not provided.

Event Description

Related manufacturer report number 1627487-2020-32622.It was reported that the patient's lead implant wound reopened and started festering.As a result, surgical intervention occurred wherein the whole system was explanted.

Manufacturer Narrative

The reported issue of the patient undergoing a system explant due to wound dehiscence was not confirmed.This issue cannot be confirmed with product testing.The anchor was returned with part of the distal sleeve trimmed off.It functioned as intended when tested with a lab lead.A review of the production records pertinent to packaging and sterility were requested for the returned product results and will be recorded on the corresponding pi main.The root cause of the issue could not be determined.Efforts to identify the device [model number, lot number] information have been unsuccessful.Since lot number information is not available, dhr review cannot be performed.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10684484
• MDR Text Key: 211502828
• Report Number: 1627487-2020-32622
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

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 Model Number: 1192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS ANCHOR; SCS LEAD X2; SCS ANCHOR; SCS LEAD X2
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 73