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

Model Number 3788

Device Problem No Device Output (1435)

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.(b)(4).

Event Description

The patient has 2 scs systems.Please reference mfr.Report: 1627487-2016-00448 for issue regarding the other scs ipg.It was reported the patient's scs ipg became inoperable (date of event is unknown) either following a radiofrequency ablation (rfa) procedure or an automobile accident as the patient turned off her scs system for the rfa procedure and was unable to resume stimulation nor establish communication between the scs ipg and external devices afterwards.The surgeon was unable to determine if this event occurred during the rfa or if it derived from the automobile accident.An sjm representative confirmed the issue.Surgical intervention will be taken at a later date to address the issue.

Event Description

Additional information received identified the patient's scs ipg was explanted and replaced.Stimulation was restored following the surgical intervention.

Event Description

After further review, it was determined that it should be noted that the patient turned off stimulation for the rfa procedure in (b)(6) 2015 and did not turn stimulation back on afterwards.

• 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: 5401838
• MDR Text Key: 37232950
• Report Number: 1627487-2016-00463
• Device Sequence Number: 1
• Product Code: GZB
• 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,Followup,Followup
• Report Date: 03/09/2016

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: 10/28/2013
• Device Model Number: 3788
• Device Lot Number: 3527440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2016
• Initial Date FDA Received: 02/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/19/2016; 04/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2011
• 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