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

Model Number 1192

Device Problem Material Fragmentation (1261)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/05/2022

Event Type  Injury  

Event Description

Related manufacturer report number: 1627487-2022-00859, 3006705815-2022-00265, 3006705815-2022-00266.It was reported that patient underwent surgical intervention on (b)(6) 2022 in which the leads were explanted and replaced.During the procedure it was found that one anchor was fragmented.Only that fragmented anchor was explanted, but both were replaced.Note: it is unknown which anchor was fragmented so both are being reported.

Manufacturer Narrative

The reported event of damage/material integrity problem was visually confirmed.As received, the anchor was incomplete and was damage beyond functional testing.No checklist was initiated per 56-0258 as the complaint can be confirmed through visual inspection.The cause is consistent with damage while in vivo.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 13537129
• MDR Text Key: 285642343
• Report Number: 1627487-2022-00858
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2023
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7911870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCS IPG
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 104 KG