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

Model Number 3788

Device Problem Device Stops Intermittently (1599)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported the patient (b)(6) experienced their ipg shut off by itself.In turn, their scs system was explanted.Also, the patient's extension was electively explanted on the same day as the patient's ipg.The patient's lead was explanted on (b)(6)2017 and reported under mfr.Report# 1627487-2017-03177.Note: their ipg was also reported as explanted under mfr.Report# 1627487-2017-03179.

• 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: 6645434
• MDR Text Key: 77702395
• Report Number: 1627487-2017-03214
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2015
• Device Model Number: 3788
• Device Lot Number: 4136482
• Other Device ID Number: 05414734402651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2017
• Initial Date FDA Received: 06/15/2017
• Supplement Dates Manufacturer Received: 07/01/2017
• Supplement Dates FDA Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2013
• 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
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 60