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

Model Number 3788

Device Problems Device Stops Intermittently (1599); Device Inoperable (1663)

Patient Problems Fall (1848); Inadequate Pain Relief (2388)

Event Date 09/25/2017

Event Type  Injury  

Manufacturer Narrative

Abbott 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.Abbott defers to the patient¿s physician regarding medical history.

Event Description

It was reported the patient had intermittent stimulation after falling down the stairs.The patient stated the scs stimulation has been turning on and off on its own.The company representative was unable to communicate with the ipg.Surgical intervention was scheduled for ipg replacement.

Event Description

Follow up information indicated the patient had surgery to replace the ipg.Reportedly post-operatively the patient's stimulation was restored.

• Brand Name: EON MINI 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: 7029093
• MDR Text Key: 91943231
• Report Number: 1627487-2017-07242
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2017
• Device Model Number: 3788
• Device Lot Number: 4945340
• Other Device ID Number: 05414734402651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2015
• 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 3246 SCS LEADS ( X 2)
• Patient Outcome(s): Other
• Patient Age: 51 YR