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

Model Number 1192

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2020

Event Type  Injury  

Manufacturer Narrative

The results, method, and conclusion codes along with the investigation results will be provided in final report.

Event Description

Related manufacturer reference number: 3006705815-2020-32354; related manufacturer reference number: 3006705815-2020-32355; related manufacturer reference number: 1627487-2020-33151.It was reported the patient experienced ineffective stimulation following a fall.Xray imaging identified lead migration as well as lead fractures and one anchor fracture.Surgical intervention was undertaken wherein both of the patients leads and the fractured anchor were explanted and replaced.Surgical intervention addressed the issue.Note: both anchors are being reported as it is unknown which anchor was effected.

Manufacturer Narrative

The results of the investigation are inconclusive, and the root cause of the reported incident is unknown as the device was not returned for analysis.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10765581
• MDR Text Key: 214150690
• Report Number: 1627487-2020-33152
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2022
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7444535
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 11/04/2020
• Supplement Dates FDA Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS ANCHOR; SCS LEAD (X2)
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 60