MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 10CM; SCS EXTENSION

Model Number 3341

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/15/2020

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 number: 3006705815-2020-02371.Related manufacturer reference number: 1627487-2020-21952.Related manufacturer reference number: 1627487-2020-21953.Related manufacturer reference number: 1627487-2020-21954.Related manufacturer reference number: 1627487-2020-21956.It was reported that the patient experienced ineffective therapy and stopped using the system.Patient does not prefer any troubleshooting performed.In turn, surgical intervention may take place at a later date to address the issue.

Manufacturer Narrative

The reported event of ineffective stimulation could not be confirmed due to insufficient product returned.Lead extensions were cut and incomplete; consistent with explant procedure.Only two terminal end segments were returned and passed electrical testing.No root cause was identified for reported event.

Event Description

Additional information received indicates that surgical intervention took place on (b)(6)2020 wherein the entire system was explanted.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 10CM
• Type of Device: SCS EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10220777
• MDR Text Key: 197209514
• Report Number: 1627487-2020-21955
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734402279
• UDI-Public: 05414734402279
• Combination Product (y/n): N
• PMA/PMN Number: K960728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2018
• Device Model Number: 3341
• Device Catalogue Number: 3341
• Device Lot Number: 5756508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS EXTENSION; SCS IPG; SCS LEAD X3; SCS EXTENSION; SCS IPG; SCS LEAD X3
• Patient Outcome(s): Other