MAUDE Adverse Event Report: ST. JUDE MED - NEUROMODULATION EON; SCS IPG

Model Number 3716

Device Problems Low impedance (2285); Delayed Charge Time (2586)

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

Event Date 04/02/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr.Report: 1627487-2014-24225.The patient received 2 leads with the same lot number.It was reported the patient has been experiencing overstimulation for approximately 4 to 5 months.Diagnostics indicated some low impedance values.X-rays revealed the left lead had migrated.Additionally, the patient experienced increased recharge burden.Subsequently, the patient underwent surgical intervention to replace the ipg and implant a new lead.Stimulation was restored postoperatively.

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 2.Reference mfr report: 1627487-2014-24225.

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.

• Brand Name: EON
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MED - NEUROMODULATION; plano TX
• Manufacturer Contact: jane mwambu ; 6901 preston rd.; plano, TX 75024 ; 9723098568
• MDR Report Key: 4132644
• MDR Text Key: 4924672
• Report Number: 1627487-2014-24224
• 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,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2016

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: 10/01/2007
• Device Model Number: 3716
• Device Lot Number: 46558A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/02/2014
• Initial Date FDA Received: 09/24/2014
• Supplement Dates Manufacturer Received: 06/09/2016; 06/09/2016
• Supplement Dates FDA Received: 01/02/2015; 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR