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

Model Number 3688

Device Problems Fluid/Blood Leak (1250); High impedance (1291); Low impedance (2285)

Patient Problems Discomfort (2330); Inadequate Pain Relief (2388)

Event Date 09/22/2015

Event Type  Injury  

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.

Event Description

Device 1 of 4, reference mfr.Report# 1627487-2015-20574, reference mfr.Report# 1627487-2015-20575, reference mfr.Report# 1627487-2015-20579.It was reported the patient (australia) experienced ineffective stimulation and unpleasant stimulation.Additionally, the patient also experienced intermittent stimulation at the ipg pocket site.System diagnostics determined low and high impedances on some contacts.Consequently, the patient underwent surgical intervention.During the surgery the physician observed fluid in the ipg/extension header.Intraoperative testing done after removing the extensions revealed normal impedances.The physician explanted and replaced the ipg and leads with a different model which resolved the issues.

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

Device 1 of 4.Reference mfr.Report# 1627487-2015-20574, reference mfr.Report# 1627487-2015-20575, reference mfr.Report# 1627487-2015-20579.

• 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: 5156474
• MDR Text Key: 28518821
• Report Number: 1627487-2015-20573
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 3688
• Device Lot Number: 3625033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2012
• 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