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

Model Number 3716

Device Problems Corroded (1131); High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

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 2.Reference mfr.Report:1627487-2015-03514.It was reported the patient (b)(6) is no longer receiving stimulation.Diagnostics revealed high impedance values.X-rays revealed no anomalies.As a result, the patient underwent exploratory surgery in (b)(6) of 2015 (exact date is unknown at this time) during which corrosion in the scs ipg header and on the scs extension contacts was found.Surgical intervention regarding the scs ipg and scs extension will be taken at a later date to address the issue.

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 3.Reference mfr.Report:1627487-2015-03514 & 1627487-2016-01198.Additional information received identified the patient underwent surgical intervention on (b)(6) 2016 during which the scs ipg and scs extensions (it was determined the patient had 2 extensions) were explanted and replaced.The other scs extension (lot, manufacture and expiration dates are unknown) is being reported as device 3.

Event Description

Device 1 of 5.Reference mfr.Report:1627487-2015-03514, 1627487-2016-01198, 1627487-2016-01306, & 1627487-2016-01307.Additional information received identified the scs leads (device 2 &3) are from the same lot.It was also reported the issue was resolved with the explant and replacement of the ipg and extensions.As a result, surgical intervention regarding the scs leads will be taken at a later date to address the issue.The scs leads (both devices have (b)(4) serial numbers) are being reported as device 4 and device 5 respectively.

Event Description

Device 1 of 5: reference mfr.Report:1627487-2015-03514, 1627487-2016-01198, 1627487-2016-01306, & 1627487-2016-01307.

• Brand Name: EON RECHARGEABLE IPG, 16-CHANNEL
• 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: 5188223
• MDR Text Key: 29848115
• Report Number: 1627487-2015-03513
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 3716
• Device Lot Number: 4150465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2013
• 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