MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON C 16-CHANNEL IPG; SCS IPG

Model Number 3688

Device Problems Self-Activation or Keying (1557); Device Stops Intermittently (1599)

Patient Problem Anxiety (2328)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Device 1 of 2.Reference mfr report #: 1627487-2017-01037.It was reported the patient's ipg had been turning on and off itself which was causing anxiety according to the patient.The patient also stated she could hear the device even when it was off.As a result, the patient will undergo surgical intervention.

• Brand Name: EON C 16-CHANNEL IPG
• 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: 6374964
• MDR Text Key: 68965035
• Report Number: 1627487-2017-01036
• Device Sequence Number: 1
• Product Code: LGW
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2015
• Device Model Number: 3688
• Device Lot Number: 4339686
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2013
• 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: 3219, SCS LEAD; MODEL: 3228, SCS LEAD
• Patient Outcome(s): Other