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

Model Number 3286

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Nausea (1970)

Event Date 03/13/2014

Event Type  Injury  

Event Description

Device #1 of 2.Reference mfr report: 1627487-2014-26271.The pt had with two model 3066 leads with the same lot number.It was reported the pt underwent a trial procedure and experienced nausea the following day.The pt was treated with antiemetic medications.Pt also experienced high blood sugar and went to the local hospital and was treated with iv fluids and insulin.The pt's issues are now resolved.

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: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 3733454
• MDR Text Key: 17262294
• Report Number: 1627487-2014-26272
• 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: 03/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2015
• Device Model Number: 3286
• Device Lot Number: 4334893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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
• Patient Outcome(s): Other
• Patient Age: 43 YR