MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/4MM, 90 CM; SCS LEAD

Model Number	3149
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Device Overstimulation of Tissue (1991)
Date of Event	08/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Date of explant is unknown.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Related manufacturer reference number: 1627487-2020-30596, related manufacturer reference number: 1627487-2020-30597, related manufacturer reference number: 1627487-2020-30598.It was reported that patient experienced uncomfortable stimulation.As a result, surgical intervention was undertaken at unknown date wherein the entire system was explanted.

• Brand Name: QUATTRODE LEAD, 3/4MM, 90 CM
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10480491
• Report Number: 1627487-2020-30599
• Device Sequence Number: 16778182
• Product Code: LGW
• UDI-Device Identifier: 05414734401593
• UDI-Public: 05414734401593
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

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: 04/28/2013
• Device Model Number: 3149
• Device Catalogue Number: 3149
• Device Lot Number: 3371463
• 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: 08/17/2020
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Weight: 73