MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S8; SCS LEAD

Model Number 3288

Device Problems Kinked (1339); Device Stops Intermittently (1599); Impedance Problem (2950)

Patient Problems Fall (1848); Shock (2072); Inadequate Pain Relief (2388)

Event Date 04/22/2014

Event Type  Injury  

Event Description

It was reported the pt was experiencing intermittent and ineffective stimulation.An sjm rep met with the pt for scs sys troubleshooting, at which time the pt stated he fell twice in the past year and was unable to feel stimulation on most programs.Multiple contacts were determined to have invalid impedances.X-rays were taken of pt's ipg site but did not reveal any anomalies other than small kinks in wires.Pt was scheduled for a sys revision but later decided to not move forward with any intervention at this time.

Manufacturer Narrative

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: LAMITRODE S8
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: logan farmer ; 6901 preston rd.; plano, TX 75024 ; 9725269611
• MDR Report Key: 3961037
• MDR Text Key: 4561984
• Report Number: 1627487-2014-08118
• 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: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2012
• Device Model Number: 3288
• Device Lot Number: 3071786
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2010
• 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: IMPLANT DATE:; SCS IPG, MODEL 3788
• Patient Outcome(s): Other
• Patient Age: 52 YR