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

Model Number 1192

Device Problem Break (1069)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/25/2020

Event Type  Injury  

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.

Event Description

Related manufacturer reference number: 3006705815-2020-02649; related manufacturer reference number: 3006705815-2020-02650; related manufacturer reference number: 1627487-2020-22514.It was reported the during a lead replacement procedure (related manufacturer reference number: 3006705815-2020-02173 & 3006705815-2020-02174), it was discovered that one lead and one anchor were found to be broken.As a result, the lead and anchor were explanted and replaced on (b)(6) 2020.Issue resolved.It is unknown which lead and anchor were broken; therefore both will be reported.

Manufacturer Narrative

The reported event of anchor breakage was confirmed.The anchor was returned complete but broken into three pieces.The silicone material had separated from the peek material.The anchor was too damaged to perform functional testing.The breakage is consistent with the inserted lead being subjected to overstress while in vivo.Correction h6 - method code should be 10 instead of 4114, results code should be 3252 instead of 3221.The conclusion code should be 4307 instead of 4315.

• 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: 10240098
• MDR Text Key: 197799534
• Report Number: 1627487-2020-22515
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 6423858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS ANCHOR; SCS LEAD (X2); SCS ANCHOR; SCS LEAD (X2)
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 91