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

Model Number	MN10350-50A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation results will be provided in the final report.
Event or Problem Description
Device 2 of 2, mfg report reference: 1627487-2019-04173.It was reported that the patient was having symptoms of an infection during a trial.The patient reported fever, chills and pain at the procedure site.The patient was hospitalized and received a pic line to treat the infection.The trial was ended early and the leads were removed.

• Brand Name: 50CM TRIAL LEAD KIT, SLIM TIP
• Common Device Name: DRG LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 8482916
• Report Number: 1627487-2019-04174
• Device Sequence Number: 1761457
• Product Code: PMP
• UDI-Device Identifier: 05415067025517
• UDI-Public: 05415067025517
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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: 06/30/2019
• Device Model Number: MN10350-50A
• Device Catalogue Number: MN10350-50A
• Device Lot Number: AB2356
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 05/19/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 05/20/2019
• 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 MN10350-50A, DRG LEAD
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 35 YR