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

Model Number	3156
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/21/2019
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
Related manufacturer reference number 1627487-2019-13489 and 1627487-2019-13490.It was reported diagnostics indicated high impedance readings.Reprogramming was unable to provide effective therapy.The patient started a bte trial which was successful.As a result, surgical intervention may take place to address this issue.
Additional Manufacturer Narrative
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
It was reported that the patient underwent surgical intervention on (b)(6) 2020 wherein the patient had their leads and ipg explanted and replaced.Therapy has been restored post-op.
Additional Manufacturer Narrative
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.

• Brand Name: QUATTRODE LEAD, 3/6MM, 60 CM
• Common Device Name: PERCUTANEOUS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 9427004
• Report Number: 1627487-2019-13487
• Device Sequence Number: 484360
• Product Code: LGW
• UDI-Device Identifier: 05414734406079
• UDI-Public: 05414734406079
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/18/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2016
• Device Model Number: 3156
• Device Catalogue Number: 3156
• Device Lot Number: 4606870
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 12/16/2019; 02/13/2020; 03/12/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 12/17/2019; 02/28/2020; 03/18/2020
• 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: SCS IPG; SCS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 64