MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, 60CM; SCS EXTENSION

Model Number 3386

Device Problems Impedance Problem (2950); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/28/2019

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.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 event could not be conclusively determined.

Event Description

Manufacturer report number 1627487-2019-12806.It was reported that the patient was experiencing ineffective stimulation due to autoreducing.In result, surgical intervention was undertaken on (b)(6) 2019 where both extensions were explanted and replaced.Effective therapy was restored after procedure.

Manufacturer Narrative

(b)(4).

• Brand Name: EXTENSION, 60CM
• 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: 9349015
• MDR Text Key: 167204574
• Report Number: 1627487-2019-12807
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734402330
• UDI-Public: 05414734402330
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: 3386
• Device Catalogue Number: 3386
• Device Lot Number: 5353758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2016
• 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
• Treatment: MODEL 3386, SCS EXTENSION
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Weight: 113