MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S-8 LEAD KIT, 90CM LENGTH; SCS LEAD

Model Number	3268
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Fall (1848); Inadequate Pain Relief (2388)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation results will be provided in the final report.
Event or Problem Description
It was reported the patient experienced a fall and as a result lost stimulation.Diagnostics indicated that the patient had high impedances on the cervical lead.Surgical intervention may be pending to address the 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
Additional information received indicated the patient underwent surgical intervention to address the reported issue wherein the lead was explanted and a new lead was not implanted due to excess scar tissue.

• Brand Name: LAMITRODE S-8 LEAD KIT, 90CM LENGTH
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 8638212
• Report Number: 1627487-2019-05997
• Device Sequence Number: 1992711
• Product Code: LGW
• UDI-Device Identifier: 05414734402194
• UDI-Public: 05414734402194
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2020

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: 05/28/2016
• Device Model Number: 3268
• Device Catalogue Number: 3268
• Device Lot Number: 4591286
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 06/18/2019; 05/28/2020
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 06/26/2019; 06/16/2020
• 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 Weight: 109