MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S-4 LEAD KIT, 90CM LENGTH; SCS LEAD

Model Number	3266
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Electric Shock (2554)
Date of Event	07/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event and therapy dates are estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer reference numbers: 1627487-2020-01166.1627487-2020-01168.It was reported that the patient experienced a shocking sensation.As a result, surgical intervention occurred to explant and replace the leads and extension.The exact surgery date is not known.The patient also had a system explant due to a shocking sensation, documented in related manufacturer reference numbers: 1627487-2020-01164, 1627487-2020-01165.
Additional Manufacturer Narrative
During processing of this complaint, patient weight could not be obtained.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.Patient and device codes were corrected.

• Brand Name: LAMITRODE S-4 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: 9672238
• Report Number: 1627487-2020-01167
• Device Sequence Number: 2913553
• Product Code: LGW
• UDI-Device Identifier: 05414734402170
• UDI-Public: 05414734402170
• 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: 2009
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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: 10/28/2011
• Device Model Number: 3266
• Device Catalogue Number: 3266
• Device Lot Number: 2870867
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 02/09/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 02/20/2020
• 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 EXTENSION; SCS LEAD
• Outcome Attributed to Adverse Event: Other