MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION SWIFT-LOCK ANCHOR; SCS ANCHOR

Model Number 1192

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2020

Event Type  Injury  

Manufacturer Narrative

The results/ method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference # 1627487-2020-31510.It was reported that during a lead revision procedure (3006705815-2020-31282 & 3006705815-2020-31283) on (b)(6) 2020, the physician discovered that the nodes of both anchors on both leads separated from the barrell.The physician was able to find them and remove them.

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete event, patient and device information.The event of a full system explant due to an anchor issue was reported to abbott.During a lead revision procedure (manufacturer report numbers 3006705815-2020-31282 and 3006705815-2020-31283) it was discovered that the nodes of both anchors on both leads separated from the barrel.The doctor located the nodes and was able to remove them.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): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10544862
• MDR Text Key: 207283174
• Report Number: 1627487-2020-31507
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2022
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7366920
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS ANCHOR; SCS ANCHOR
• Patient Outcome(s): Other
• Patient Age: 48 YR