MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S-8 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number	3286
Medical Device Problem Codes	High impedance (1291); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that the patient experienced ineffective therapy.Impedance reading showed high impedances.X-ray indicated that the lead migrated from middle to the right side of the epidural space.As such, surgical intervention took place on (b)(6) 2020 wherein the lead was explanted and replaced with a new lead to address the issue.
Additional Manufacturer Narrative
The report event of lead migration cannot be confirmed with product testing alone.As received, the paddle lead showed no compression mark on the outer tubing.Setscrew marks were present on last terminal end contact, which indicated the lead was secured.No root cause was identified for reported event.

• Brand Name: LAMITRODE S-8 LEAD KIT, 60CM LENGTH
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 9765257
• Report Number: 1627487-2020-02142
• Device Sequence Number: 2511560
• Product Code: LGW
• UDI-Device Identifier: 05415067017833
• UDI-Public: 05415067017833
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

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: 04/05/2018
• Device Model Number: 3286
• Device Catalogue Number: 3286
• Device Lot Number: 5449977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 05/05/2020
• 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