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

Model Number 3383

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 03/11/2014

Event Type  Injury  

Event Description

Device 3 of 3.Reference mfr report #1627487-2014-12136, reference mfr report #1627487-2014-12194.

Manufacturer Narrative

Results - the complaint was confirmed.Microscopic inspection revealed a broken wire at one of the weld spots, making a faulty contact with one channel.The broken wire was consistent with an overstress condition the extension was subjected to while it was inside the pt.Sjm has limited information related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: SINGLE EXTENSION
• Type of Device: SCS EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: connie timmons ; 6901 preston road; plano, TX 75024 ; 9723098054
• MDR Report Key: 3723828
• MDR Text Key: 4326883
• Report Number: 1627487-2014-12195
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2015
• Device Model Number: 3383
• Device Lot Number: 4075595
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/14/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• 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: SCS IPG: MODEL: 3788; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 44 YR