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

Model Number	1192
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer report number: 1627487-2022-03537, 1627487-2022-03539.It was reported that the patient loss therapy due to high impedances on both leads.It was noted that the patient had a fall.As a result, the patient underwent surgical intervention to address the issue.During the procedure, it was noted that one of the anchors had broken into 2 pieces.In turn, the leads and anchor were explanted and replaced.Effective therapy was established post-operatively.
Additional Manufacturer Narrative
Date of event is estimated.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.The allegation is against 1 of 2 anchors; however, it is unknown which anchor, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: swift-lock anchor, model: 1192ans, udi: (b)(4), batch: 6714560.

• Brand Name: SWIFT-LOCK ANCHOR
• Common Device Name: SCS LEAD 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: 16641136
• Report Number: 1627487-2023-01429
• Device Sequence Number: 12301186
• Product Code: GZB
• UDI-Device Identifier: 05414734400671
• UDI-Public: 05414734400671
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K092371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2020
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 6714560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCS IPG; SCS LEAD ANCHOR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 70 KG