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

Model Number MN10450-50A

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

Patient Problems Death (1802); Coma (2417)

Event Date 06/19/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

Related manufacturer reference number: 1627487-2019-07679, related manufacturer reference number: 1627487-2019-07685.It was reported the patient had a dorsal root ganglion (drg) system implanted and postoperatively was unable to be awakened.No complications were noted during the procedure.Patient was transported to another medical facility and died on (b)(6) 2019.The cause of death is unknown and an autopsy is pending.There is no allegation from a healthcare professional that the death was related to the system; rather it is suspected to be due to the procedure.

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete event information, but it was not received.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.

• Brand Name: 50CM IMPLANT LEAD KIT, SLIM TIP
• Type of Device: DRG 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
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8772794
• MDR Text Key: 150454433
• Report Number: 1627487-2019-07678
• 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: 08/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2021
• Device Model Number: MN10450-50A
• Device Lot Number: 6909887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2019
• 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: MODEL 3664, DRG IPG; MODEL MN10450-50A, DRG LEAD
• Patient Outcome(s): Death; Hospitalization; Other
• Patient Weight: 110