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

Model Number 1192

Device Problem Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/27/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer report 3006705815-2021-02829.Related manufacturer report 3006705815-2021-02830.Related manufacturer report 1627487-2021-14758.It was reported that lead migration issue was confirmed via x-ray imaging.Upon explant of the right lead, the anchor came out of the fascia and the lead was coiled around the anchor site.The anchor was explanted.It is unknown which anchor has the issue therefore both anchors are being reported.Patient was stable.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11982944
• MDR Text Key: 255617552
• Report Number: 1627487-2021-14759
• 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: 06/16/2021

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 Expiration Date: 08/01/2021
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7104399
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 06/11/2021
• Supplement Dates Manufacturer Received: 06/14/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS ANCHOR; SCS LEADS X2; SCS ANCHOR; SCS LEADS X2
• Patient Outcome(s): Other
• Patient Weight: 91