MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION KIT TRIAL SLIM TIP LEAD, 90CM; DRG LEAD

Model Number	MN10350-90A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Vomiting (2144); Discomfort (2330)
Date of Event	05/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Related manufacturer report number: 1627487-2020-21467.It was reported the patient the patient had a fever that lasted two days and was vomiting.Patient also reported a pulling in their low back when looking down.As a result, the patient had their trial system removed.The fever later subsided and the patient stopped vomiting.

• Brand Name: KIT TRIAL SLIM TIP LEAD, 90CM
• Common Device Name: DRG LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10143636
• Report Number: 1627487-2020-21465
• Device Sequence Number: 11725449
• Product Code: PMP
• UDI-Device Identifier: 05415067027146
• UDI-Public: 05415067027146
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2020

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: 07/31/2021
• Device Model Number: MN10350-90A
• Device Catalogue Number: MN10350-90A
• Device Lot Number: 7044365
• 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: 05/21/2020
• Initial Report FDA Received Date: 06/11/2020
• 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: DRG LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Weight: 77