MAUDE Adverse Event Report: SALUDA MEDICAL PTY LTD EVOKE SCS SYSTEM; SCS LEAD

Model Number EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM

Device Problem High impedance (1291)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2024

Event Type  Injury  

Event Description

During the implant of an evoke spinal cord stimulation (scs) system, the lead was inserted into the closed loop stimulator (cls) header, the set screw was tightened and disconnected electrodes were identified.An attempt to reposition the lead in the cls was unsuccessful, as the lead could not be removed.The physician made the decision to complete the procedure with the disconnections since the second lead was showing impedances within range.A revision procedure was performed, and the lead was able to be removed and reinserted in the header.Following the procedure, the impedances were within range.

Manufacturer Narrative

Investigation of this event is in progress.Once the investigation is complete, a supplemental report will be submitted.

Manufacturer Narrative

Additional information: section g3 - date received by manufacturer.Section h6 - evaluation codes.Section h10 - manufacturer narrative.The evoke spinal cord stimulation (scs) system remains implanted.The cause of the reported disconnected electrode and lead removal difficulty could not be determined.Log review confirmed the reported event, and the reported disconnected electrodes were resolved post procedure.The manufacturing records were reviewed.The product met all requirements for release, and no anomalies were identified.

• Brand Name: EVOKE SCS SYSTEM
• Type of Device: SCS LEAD
• Manufacturer (Section D): SALUDA MEDICAL PTY LTD; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• Manufacturer (Section G): SALUDA MEDICAL PTY LTD; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• Manufacturer Contact: sadie mauser ; 5 eden park drive; macquarie park, nsw 2113 ; AS 2113
• MDR Report Key: 18976271
• MDR Text Key: 338552251
• Report Number: 3021836309-2024-00215
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 09352307000773
• UDI-Public: 09352307000773
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190002
• 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,Followup
• Report Date: 05/15/2024

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 Model Number: EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM
• Device Catalogue Number: 3008
• Device Lot Number: 9015604946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 04/20/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• 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
• Patient Outcome(s): Other