MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 60CM; SCS LEAD EXTENSION

Model Number 3346

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer reference number: 1627487-2019-09068, 1627487-2019-09069, 1627487-2019-09070, 1627487-2019-09071, 3006705815-2019-03032.It was reported that patient had the entire scs system explanted due to ineffective stimulation.Reprogramming was unable to resolve the issue prior to explant.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 60CM
• Type of Device: SCS LEAD 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: 8885294
• MDR Text Key: 154031539
• Report Number: 1627487-2019-09072
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734402309
• UDI-Public: 05414734402309
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2019

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: 01/24/2020
• Device Model Number: 3346
• Device Catalogue Number: 3346
• Device Lot Number: 6287996
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2018
• 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 3166 SCS LEAD (2); MODEL 3169, SCS LEAD; MODEL 3346 SCS LEAD EXTENSION; MODEL 3772, SCS IPG
• Patient Outcome(s): Other
• Patient Weight: 54