MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE 4 LEAD KIT, 60CM LENGTH; SCS PADDLE LEAD

Model Number	3240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Rash (2033)
Date of Event	02/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.Date of event is estimated.Additional patient information not received.
Event or Problem Description
Related manufacturing report number: 3006705815-2020-00975; related manufacturing report number: 1627487-2020-02294; related manufacturing report number: 1627487-2020-02295; related manufacturing report number: 1627487-2020-02296; related manufacturing report number: 1627487-2020-02298; related manufacturing report number: 1627487-2020-02299.It was reported that the patient had numerous staph infections near or at the ipg and incision sites.The patient also reported various rashes.It was determined that the patient was allergic to the ipg and/or leads.The patient underwent surgical intervention wherein the entire scs system was explanted.

• Brand Name: LAMITRODE 4 LEAD KIT, 60CM LENGTH
• Common Device Name: SCS PADDLE LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 9788531
• Report Number: 1627487-2020-02297
• Device Sequence Number: 618415
• Product Code: LGW
• UDI-Device Identifier: 05414734406192
• UDI-Public: 05414734406192
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2020

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: 02/28/2017
• Device Model Number: 3240
• Device Catalogue Number: 3240
• Device Lot Number: 5029501
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/04/2020
• 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 (X2); SCS IPG; SCS LEAD (X3)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR