MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/6MM, 60 CM; SCS LEAD

Model Number	3156
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Inadequate Pain Relief (2388)
Date of Event	11/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Device 1 of 3: reference mfr.Report: 1627487-2018-13000, reference mfr.Report: 1627487-2018-13001, reference mfr.Report: 1627487-2018-13002.It was reported the patient suffered a fall and then experienced ineffective stimulation.To address the issue, the physician explanted and replaced the patient¿s three leads.Postoperatively, effective therapy was restored.
Event or Problem Description
Device 1 of 3:reference mfr.Report: 1627487-2018-13001,reference mfr.Report: 1627487-2018-13002.

• Brand Name: QUATTRODE LEAD, 3/6MM, 60 CM
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 8185156
• Report Number: 1627487-2018-13000
• Device Sequence Number: 13998027
• Product Code: LGW
• UDI-Device Identifier: 05414734406079
• UDI-Public: 05414734406079
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019

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: 01/31/2017
• Device Model Number: 3156
• Device Lot Number: 4990099
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 12/31/2018
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 01/02/2019
• 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 3156, SCS LEAD; MODEL 3186, SCS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR