MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION TRIAL LEAD KIT, SLIM TIP, 50CM; DRG LEAD

Model Number	MN10350-90A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2019
Type of Reportable Event	Serious Injury
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
Related manufacturer reference number: 1627487-2019-09938.It was reported that the patient's drg trial procedure was abandoned.The physician could not place the leads due to the leads kinking while being placed.No new product was implanted.

• Brand Name: TRIAL LEAD KIT, SLIM TIP, 50CM
• Common Device Name: DRG LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 8951785
• Report Number: 1627487-2019-09939
• Device Sequence Number: 2768948
• Product Code: PMP
• UDI-Device Identifier: 05415067027146
• UDI-Public: 05415067027146
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2019

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: 04/07/2021
• Device Model Number: MN10350-90A
• Device Catalogue Number: MN10350-90A
• Device Lot Number: 6934596
• 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: 08/22/2019
• Initial Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 43