MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION; SCS EXTENSION

Model Number 3382

Device Problems High impedance (1291); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/03/2019

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 1627487-2019-13982.It was reported that the patient was experiencing ineffective therapy.As a result, surgical intervention took place on (b)(6) 2020 wherein the patient had their lead and extension explanted and replaced.High impedance levels were noted during the revision and were normal once the lead and extension were explanted and replaced.The extension has been added as an additional reportable device.

Manufacturer Narrative

Obtained data: the correct model number, lot number, expiration date, udi, date of implant, pma/510(k), and device manufacture date have been provided.Corrected data : the device product code was erroneously reported on.The correct device product code has been provided.

Manufacturer Narrative

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.

• Type of Device: SCS EXTENSION
• 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: 9668742
• MDR Text Key: 177745196
• Report Number: 1627487-2020-01223
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K000852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2012
• Device Model Number: 3382
• Device Lot Number: 3263527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: 02/12/2020; 04/13/2020
• Supplement Dates FDA Received: 03/03/2020; 04/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2010
• 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