MAUDE Adverse Event Report: ST JUDE MEDICAL - NEUROMODULATION LAMITRODE TRIPOLE 16; SCS LEAD

Model Number 3219

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

Patient Problems Edema (1820); Hypersensitivity/Allergic reaction (1907)

Event Date 01/12/2014

Event Type  Injury  

Event Description

It was reported the pt experienced swelling at the lead site, blister at the tape site and a fever.The pt relates this to an allergic reaction to the tape.The pt was advised to return to see the physician but declined.The allergic response has resolved and without intervention.

Manufacturer Narrative

Sjm has limited info related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

• Brand Name: LAMITRODE TRIPOLE 16
• 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: 3682489
• MDR Text Key: 22261538
• Report Number: 1627487-2014-26087
• 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: 01/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2014
• Device Model Number: 3219
• Device Lot Number: 3855722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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: IMPLANT DATE:; SCS IPG: MODEL 3788
• Patient Outcome(s): Other
• Patient Age: 23 YR