MAUDE Adverse Event Report: ABBOTT MEDICAL SWIFT-LOCK ANCHOR

Model Number 1192

Device Problem Break (1069)

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

Event Date 05/21/2021

Event Type  Injury  

Manufacturer Narrative

Event date is an estimate.

Event Description

Related manufacturer report number: 1627487-2021-14842, 3006705815-2021-02748, 3006705815-2021-02749.It was found during lead revision procedure that one of the patient¿s lead anchors had broken into two pieces.The anchor was replaced.It is unknown which anchor was broken so both are being reported.

Manufacturer Narrative

The reported event of broken anchor/damage/material integrity problem was visually confirmed.As received, the anchor was complete and broken into two pieces.It passed functional testing.No checklist was initiated per 56-0258 as the complaint can be confirmed through visual inspection.The cause is consistent with damage the anchor was subject to while in vivo.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11999998
• MDR Text Key: 256222875
• Report Number: 1627487-2021-14841
• 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: 07/20/2021

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: 03/25/2020
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 6366468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2021
• Initial Date FDA Received: 06/15/2021
• Supplement Dates Manufacturer Received: 07/15/2021
• Supplement Dates FDA Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANCHOR, MODEL 1192; ANCHOR, MODEL 1192
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 68