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 Problems Device Overstimulation of Tissue (1991); Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Device 1 of 3.Reference mfr.Report: 1627487-2016-05249.Reference mfr.Report: 1627487-2016-05320.It was reported the patient ((b)(6)) presented to the emergency room due to having experienced unpleasant sensations all over the body which in turn resulted in a 'wound'.Additionally, the patient stated stimulation randomly turns off.Diagnostic testing did not reveal any anomalies.Surgical intervention is planned to address 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 3.Reference mfr.Report: 1627487-2016-05249, reference mfr.Report: 1627487-2016-05320.Follow-up identified surgical intervention took place on (b)(6) 2016 during which time the patient's ipg and lead were explanted and replaced.All reported issues were resolved following the procedure.

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: 1627487-2016-05249, reference mfr.Report: 1627487-2016-05320.

Manufacturer Narrative

Corrected data: the extension was not part of the patient's permanent implant system.

Event Description

Device 1 of 3: reference mfr.Report: 1627487-2016-05249, reference mfr.Report: 1627487-2016-05320.Further review of the event identified the extension (device 3) was inadvertently reported.The extension was implanted at the trial procedure, and removed thereafter at the permanent procedure.

• 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: 6020046
• MDR Text Key: 57059670
• Report Number: 1627487-2016-05248
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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
• Report Date: 06/21/2017

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: 12/28/2016
• Device Model Number: 3788
• Device Lot Number: 4920889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/02/2016; 02/06/2017; 06/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2014
• 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: 30 YR