MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/6MM, 30 CM; SCS LEAD

Model Number	3153
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 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.The manufacturer defers to the patient's physician regarding medical history.
Event or Problem Description
Device 1 of 2, reference mfr report: 1627487-2018-05816.It was reported the patient complained of ineffective stimulation therapy from his scs system.Imaging taken revealed one of the patient's leads pulled out of the epidural space.Surgical intervention may be taken to address the issue.
Event or Problem Description
Device 1 of 2.Reference mfr report: 1627487-2018-05816.Follow up information received identified the patient's scs system was replaced with a dorsal root ganglion (drg) system.Effective stimulation therapy was reportedly achieved postoperatively.

• Brand Name: QUATTRODE LEAD, 3/6MM, 30 CM
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 7606285
• Report Number: 1627487-2018-05815
• Device Sequence Number: 1383506
• Product Code: GZB
• UDI-Device Identifier: 05414734406062
• UDI-Public: 05414734406062
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2018

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: 07/28/2016
• Device Model Number: 3153
• Device Lot Number: 4718568
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 07/16/2018
• 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 (X2), SCS ANCHOR; MODEL 3343 & 3386, SCS EXTENSION; MODEL 3688, SCS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 83