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

Model Number MN10450-50A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 03/12/2020

Event Type  Death  

Manufacturer Narrative

The results/method and conclusion codes along with the investigation results will be provided in the final report.

Event Description

Manufacturer report number: 1627487-2020-04400,1627487-2020-04401.It was reported patient had an implant procedure on (b)(6) 2020.Patient did not have any complications during the procedure.Therapy was turned on (b)(6) 2020.Patient started having shortness of breath leading to pneumonia and pulmonary embolism.Patient passed away on (b)(6) 2020.

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.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 50CM
• Type of Device: DRG SLIM TIP LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10026455
• MDR Text Key: 189922277
• Report Number: 1627487-2020-04402
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027153
• UDI-Public: 05415067027153
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2021
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: 7007987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DRG IPG; DRG LEAD
• Patient Outcome(s): Death
• Patient Weight: 113