MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/4MM, 60 CM; SCS LEAD

Model Number	3146
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	04/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer 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.Manufacturer defers to the patient's physician regarding medical history.
Event or Problem Description
Device 2 of 4: reference mfr.Report# 1627487-2018-06409; reference mfr.Report# 1627487-2018-06411; reference mfr.Report# 1627487-2018-06412.It was reported the patient never experienced effective stimulation.In turn the entire scs system was explanted.

• Brand Name: QUATTRODE LEAD, 3/4MM, 60 CM
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 7681944
• Report Number: 1627487-2018-06410
• Device Sequence Number: 1369760
• Product Code: GZB
• UDI-Device Identifier: 05414734406048
• UDI-Public: 05414734406048
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2017
• Device Model Number: 3146
• Device Lot Number: 4935455
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MODEL 1192 (2), SCS ANCHORS; MODEL 3341 (2), SCS EXTENSIONS; MODEL 3771, SCS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR