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

Model Number	EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a routine follow up post operative visit for programming, it was noted that the patient did not receive paresthesia from the right lead.X ray taken during the visit showed lead had migrated out of the epidural space.The patient continues to have pain coverage through the left lead towards the left side of their body.A revision surgery is to be scheduled.
Additional Manufacturer Narrative
As per the event, the right lead has migrated however the serial number of this device cannot be confirmed.The patient has been implanted with 2 evoke cap12 percutaneous lead kit - 60cm (us): (b)(6).
Additional Manufacturer Narrative
As at 15-sep-2023, there has been no communication that a revision has occurred.Without the return of any device for analysis, it is not possible to reach a definitive root cause.The x-ray images showing the migration were not made available.Lead migration or suboptimal placement, which may result in undesirable stimulation changes is listed as a potential risk in manufacturer's instructions for use (ifu).The manufacturing records were reviewed.Product met all requirements for release with no anomalies identified.
Event or Problem Description
During a routine follow up post operative visit for programming, it was noted that the patient did not receive paresthesia from the right lead.X ray taken during the visit showed lead had migrated out of the epidural space.The patient continues to have pain coverage through the left lead towards the left side of their body.

• Brand Name: EVOKE SCS SYSTEM
• Common Device Name: SCS LEAD
• Manufacturer (Section D): SALUDA MEDICAL PTY LTD; 407 pacific highway; artarmon, new south wales 2064 ; AS 2064
• Manufacturer (Section G): SALUDA MEDICAL PTY LTD; 407 pacific highway; artarmon, new south wales 2064 ; AS 2064
• Manufacturer Contact: sadie mauser ; 407 pacific highway; artarmon, new south wales 2064 ; AS 2064
• MDR Report Key: 17028290
• Report Number: 3012939358-2023-00185
• Device Sequence Number: 20462014
• Product Code: LGW
• UDI-Device Identifier: 09352307000773
• UDI-Public: 09352307000773
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P190002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2025
• Device Model Number: EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM
• Device Catalogue Number: 3008
• Device Lot Number: 9015055877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2023
• 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
• Patient Sex: Male