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

Model Number	3149
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	04/18/2019
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
Device 2 of 4.Reference mfr.Report#: 1627487-2019-05207, 1627487-2019-05209, 1627487-2019-05210.It was reported that the patient had high impedance.In turn, surgical intervention took place on (b)(6) 2019 wherein the patient¿s cervical system was explanted and replaced.Therapy has been restored post-op.
Event or Problem Description
Device 2 of 4.Reference mfr.Report#: 1627487-2019-05207.1627487-2019-05209.1627487-2019-05210.

• 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: 8571545
• Report Number: 1627487-2019-05208
• Device Sequence Number: 1836972
• Product Code: LGW
• UDI-Device Identifier: 05414734406055
• UDI-Public: 05414734406055
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2016
• Device Model Number: 3149
• Device Lot Number: 4751259
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 05/04/2019; 05/07/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 05/06/2019; 05/07/2019
• 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 Weight: 68