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

Model Number 1192

Device Problem Break (1069)

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

Event Date 06/17/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer reference numbers: 3006705815-2021-03219, 3006705815-2021-03220, 3006705815-2021-03221, 1627487-2021-15299, 1627487-2021-15301.It was reported that the patient experienced ineffective stimulation.As a result, the patient underwent surgical intervention on (b)(6) 2021 to reposition the migrated lead.During the procedure, it was discovered one of the anchors had broken causing the lead to migrate.The physician replaced the broken anchor and repositioned the lead into place.Post-operatively, stimulation therapy was restored.It is unknown which lead migrated or which anchor broke, therefore all leads and all anchors are being reported.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively 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: 12096977
• MDR Text Key: 259374309
• Report Number: 1627487-2021-15300
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

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: 04/20/2022
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7470814
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 06/30/2021
• Supplement Dates Manufacturer Received: 07/12/2021
• Supplement Dates FDA Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERCUTANEOUS LEAD (X3); SCS ANCHOR (X2)
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 91