MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 90CM LENGTH; SCS LEAD

Model Number 3189

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

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Type  Death  

Event Description

Device 2 of 3.Reference mfr report: 1627487-2018-06001, reference mfr report: 1627487-2018-06003.It was reported that the patient passed away from a heart attack less than a month after implant.There is no indication that the device contributed to the event.

• Brand Name: OCTRODE LEAD KIT, 90CM LENGTH
• Type of Device: SCS 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: krista weinberg ; 6901 preston road; plano, TX 75024 ; 9725268217
• MDR Report Key: 7635022
• MDR Text Key: 112221779
• Report Number: 1627487-2018-06002
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734401715
• UDI-Public: 05414734401715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• 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
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 3189
• Device Lot Number: 6329662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• 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: 1194, SCS ANCHOR (2)
• Patient Outcome(s): Death