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

Model Number 6788

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/01/2015

Event Type  Injury  

Event Description

It was reported the pateint's ((b)(6)) programmer was unable to communicate with the ipg and the programmer displayed error codes 2501 and 26fe.The issue was confirmed by an sjm representative.The charger was able to maintain communication with the ipg.The patient is pending an appointment with an sjm representative.

Manufacturer Narrative

(b)(4).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: SCS 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: 4521543
• MDR Text Key: 5407257
• Report Number: 1627487-2015-12075
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P010032
• 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: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2016
• Device Model Number: 6788
• Device Lot Number: 4589113
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2014
• 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
• Patient Outcome(s): Other