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 Code	Numbness (2415)
Date of Event	03/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with the investigation results will be provided in the final report.
Event or Problem Description
Device 2 of 2: reference mfr.Report#: 1627487-2020-04013.It was reported the patient began to experience numbness and pain in their left foot and leg a day after being implanted with drg trial leads.In turn, on (b)(6) 2020, the patient's trial leads were removed.The patient was prescribed steroids and their symptoms have improved.
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
Device 2 of 2.Reference mfr.Report#: (b)(4).Follow-up revealed the patient's issue resolved over time.

• 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: 9974056
• Report Number: 1627487-2020-04014
• Device Sequence Number: 3752342
• Product Code: PMP
• UDI-Device Identifier: 05415067027146
• UDI-Public: 05415067027146
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2020

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: 12/12/2021
• Device Model Number: MN10350-90A
• Device Catalogue Number: MN10350-90A
• Device Lot Number: 7313025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 07/07/2020
• 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: MN10350-90A, DRG LEAD; MODEL: MN10350-90A, DRG LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 136