MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION; DBS IPG

Model Number 6661

Device Problem No Device Output (1435)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/07/2019

Event Type  Injury  

Manufacturer Narrative

Investigation results will be provided in the final report.

Event Description

It was reported the patient experienced ineffective stimulation.In turn, the patient's ipg reached end of life.As a result, the patient underwent surgical intervention wherein the ipg was explanted and replaced.Therapy was restored post operatively.

• 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
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8741033
• MDR Text Key: 149403126
• Report Number: 1627487-2019-07481
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020253
• UDI-Public: 05415067020253
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140009
• 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: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2018
• Device Model Number: 6661
• Device Lot Number: 5423330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2016
• 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
• Patient Outcome(s): Other