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

Model Number 1192

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2021

Event Type  Injury  

Event Description

It was reported that during lead revision surgery on (b)(6) 2021, physician unlocked anchor to reposition the lead.Upon removal, anchor snapped and distal end remained in tissue.Physician attempted to remove broken piece of anchor which appeared to have retracted back into tissue and was extremely difficult to locate.Even using fluoroscopy, broken piece of anchor was unable to be removed.Physician was concerned about extra time taken to attempt to remove anchor and tissue damage that would occur in further attempts at removal.Therefore, it remains insitu currently.

Manufacturer Narrative

The report of a damaged anchor was confirmed.Visual inspection of the returned swift-lock anchor found it was returned incomplete and missing portions of both the distal and proximal ends.The damaged anchor could not be functionally tested due to its condition.The cause of the reported event is consistent with damage occurring while still in vivo, as noted in the event details.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11221002
• MDR Text Key: 257698737
• Report Number: 1627487-2021-00464
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734400671
• UDI-Public: 05414734400671
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2018
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 5715131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other