MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/6MM, 110 CM; SCS LEAD

Model Number 3151

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

Patient Problems Inflammation (1932); Irritation (1941)

Event Date 08/22/2017

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.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.

Event Description

Device 2 of 2.Reference mfr.Report: 1627487-2017-05347.The patient has two occipital leads.In addition, the patient was enrolled in a clinical study.It was reported the patient experienced irritation and inflammation at the lead site.The patient requested an explant of the system due to the issue.Surgical intervention may be undertaken as the next course of action.

• Brand Name: QUATTRODE LEAD, 3/6MM, 110 CM
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 6880502
• MDR Text Key: 86831045
• Report Number: 1627487-2017-05349
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2017

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: 01/31/2010
• Device Model Number: 3151
• Device Lot Number: 172488
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2017
• Initial Date FDA Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2008
• 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: 48 YR