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

Model Number 6662

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient's ipg will not communicate.The patient had an emergency brain surgery on (b)(6) 2019 and the ipg would not communicate following the surgery.The physician confirmed that therapy was turned off but the ipg was not placed into surgery mode.A field representative met with the patient and was able to recover the ipg.Effective therapy is established.

Manufacturer Narrative

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: INFINITY IPG
• 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: 8829300
• MDR Text Key: 152380842
• Report Number: 1627487-2019-08385
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020260
• UDI-Public: 05415067020260
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2019
• Device Model Number: 6662
• Device Lot Number: 6164899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/16/2017
• 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