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

Model Number 3386

Device Problem Disconnection (1171)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/23/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Reference mfr.Report number: 1627487-2019-05776; 1627487-2019-05777.It was reported that stimulation on the leads was reducing on its own.X-rays indicated the lead going into extensions have pulled out.As a result, the patient's lead and extensions were explanted and replaced.Surgical intervention resolved the patient's issue.

Event Description

Reference mfr.Report number: 1627487-2019-05776; 1627487-2019-05777.

• Brand Name: EXTENSION, 60CM
• Type of Device: SCS LEAD EXTENTION
• 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: 8619451
• MDR Text Key: 145366884
• Report Number: 1627487-2019-05775
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2017
• Device Model Number: 3386
• Device Catalogue Number: 3386
• Device Lot Number: 4945339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2015
• 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 3219, SCS LEAD; MODEL 3386, LEAD EXTENSION
• Patient Outcome(s): Other