MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 20CM; SCS EXTENSION

Model Number 3342

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Scar Tissue (2060); Inadequate Pain Relief (2388)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.Date of explant is unknown.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference numbers: 1627487-2020-01907, 1627487-2020-01908, 1627487-2020-01909, 1627487-2020-01910.It was reported that the patient experienced ineffective stimulation due to the buildup of excessive scar tissue.In turn, the patient underwent surgical intervention on an unknown date wherein the entire scs system was explanted and replaced with another manufacturer's system.No additional information is available.

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete patient information.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.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 20CM
• 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: 9741780
• MDR Text Key: 180477603
• Report Number: 1627487-2020-01911
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2011
• Device Model Number: 3342
• Device Lot Number: 2822548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2009
• 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