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

Model Number 3788

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Temperature Problem (3022)

Patient Problems Pain (1994); Swelling (2091); Burning Sensation (2146)

Event Date 02/06/2014

Event Type  Injury  

Event Description

Device 1 of 2 - reference mfr.Report 1627487-2014-21532: the patient reported experiencing persistent pain at the ipg site regardless of stimulation and stated the ipg site was swollen.Additionally, the patient experienced abdominal pain with stimulation, pocket heating/shocking sensations at the ipg site regardless of stimulation.The patient reported experiencing loss of back stimulation and unintended kidney stimulation.The patient also stated feeling shocking sensations that radiate from his spine to the lead incision site when moving or laying in bed.The patient felt similar sensations during his lead repositioning procedure (reference mfr.Report 1627487-2014-06072).The patient declined meeting with the sjm representative for further troubleshooting and requested a system explant.

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: 1627487-2014-21532 further investigation identified the patient's ipg was explanted.It is unknown at this time if the lead was explanted as well.

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 MINI
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: palka sharma ; 6901 preston road; plano, TX 75024 ; 9725264823
• MDR Report Key: 4059310
• MDR Text Key: 4907348
• Report Number: 1627487-2014-21531
• 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: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 10/27/2014

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: 12/01/2015
• Device Model Number: 3788
• Device Lot Number: 4393081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2014
• Initial Date Manufacturer Received: 10/27/2014
• Initial Date FDA Received: 08/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2013
• 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
• Patient Age: 46 YR