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 03/06/2020

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 report: 3006705815-2020-30992, related manufacturer report: 3006705815-2020-30993, related manufacturer report: 1627487-2020-30685.It was reported that patient experienced ineffective stimulation, due to lead migration issue.Upon x-ray observation lead migration was confirmed wherein one lead migrated one vertebral body and the second lead migrated half a vertebral body.Patient denies any traumas or falls.Blood work was done, and no presence of abscess was confirmed.Both leads were explanted, and new leads were implanted.During the procedure, anchor damage issue was observed.Both anchors were explanted, and new anchors were implanted.Effective therapy was established post procedure.Patient was stable.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 10457839
• MDR Text Key: 204510823
• Report Number: 1627487-2020-30684
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2020
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 6419262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2018
• 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 ANCHOR; SCS LEAD X2
• Patient Outcome(s): Other
• Patient Weight: 50