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

Model Number	3268
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of the event is 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 number: 1627487-2020-21546.Related manufacturer reference number: 1627487-2020-21547.It was reported the patient needs a lead revision.Surgical intervention may take place at a later date to address the issue.
Additional Manufacturer Narrative
Correction: section h6 - device code should have been 3189 rather than 3190.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 found that patient underwent a scar tissue revision surgery on (b)(6) 2020.No implanted products were touched or explanted.

• Brand Name: LAMITRODE S-8 LEAD KIT, 90CM LENGTH
• Common Device Name: SCS PADDLE LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10146434
• Report Number: 1627487-2020-21648
• Device Sequence Number: 3852601
• Product Code: LGW
• UDI-Device Identifier: 05414734402194
• UDI-Public: 05414734402194
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2020

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: 12/28/2015
• Device Model Number: 3268
• Device Catalogue Number: 3268
• Device Lot Number: 4382005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 07/10/2020
• 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: MODEL # 3169 (2) - LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Weight: 57