MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION BRIO IPG, 16-CHANNEL RECHARGEABLE; DBS IPG

Model Number 6788

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

Patient Problems Death (1802); Hiccups (1899)

Event Date 03/18/2015

Event Type  Injury  

Event Description

It was reported the patient (b)(6) suffered from a cerebral hemorrhage and began experiencing symptoms approximately 24 hours after her permanent procedure.Subsequently, the patient died.The physician stated the issue was related to the procedure.Additionally, it was noted the placement of the patient's leads was not relevant as the bleeding seemed to have occurred somewhere at the trajectory.It is unknown at this time if any treatment was given to the patient or if the device was later explanted.

Manufacturer Narrative

(b)(4).This device is not approved for sale in the u.S.The procode was only added for submission purposes only.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

• Brand Name: BRIO IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: DBS IPG
• 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: 4728666
• MDR Text Key: 5744224
• Report Number: 1627487-2015-25055
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2016
• Device Model Number: 6788
• Device Lot Number: 4904494
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2014
• 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: 6319(X2), DBS EXTENSIONS; MODEL: 6149, DBS LEAD
• Patient Outcome(s): Death