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

Model Number 1192

Device Problem Fracture (1260)

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

Event Date 07/27/2021

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2021-16322.It was reported that, during the patient's lead revision (related manufacturer reference number: 3006705815-2021-00936), it was discovered that one of the patient's anchors was fractured.As a result, the physician explanted and replaced both anchors.Therapy was restored following the procedure.It is unknown which anchor was fractured so both are being reported on.

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: 12324815
• MDR Text Key: 266664972
• Report Number: 1627487-2021-16323
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2018
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 5649350
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/16/2021
• Supplement Dates Manufacturer Received: 08/16/2021
• Supplement Dates FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1192; 1192
• Patient Outcome(s): Other
• Patient Weight: 73