MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EONC; SCS IPG

Model Number 3688

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/17/2014

Event Type  Injury  

Event Description

It was reported the patient (b)(6) had an allergic reaction (nickel allergy confirmed) and complained of a burning sensation.As a result, the scs system was explanted.

Manufacturer Narrative

Sjm has limited information 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: EONC
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: rachel blackwell ; 6901 preston rd.; plano, TX 75024 ; 9725264637
• MDR Report Key: 4239400
• MDR Text Key: 20753422
• Report Number: 1627487-2014-03683
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2014
• Device Model Number: 3688
• Device Lot Number: 3705622
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/28/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2014
• Initial Date FDA Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2012
• 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 EXTENSION: MODEL UNKNOWN (2); SCS LEAD: MODEL UNKNOWN (2)
• Patient Outcome(s): Other