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

Model Number 3788

Device Problem Pocket Stimulation (1463)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994)

Event Date 05/12/2009

Event Type  Injury  

Event Description

Device 1 of 3.Reference mfr report: 1627487-2014-21107, 21108.The patient reported experiencing pain at the ipg site regardless of stimulation.The patient has arthritis near the hip where the ipg is located and he likened the pain to an 'arthritis' sensation.The patient also reported feeling shocking at the ipg site, which appeared to be decreased when stimulation is off or reduced to a lower amplitude.Additionally, the patient has never received effective therapy from his system.The patient wants his scs system explanted.Follow-up identified the physician and the patient decided to leave the system implanted, and there was no intervention planned at the time.

Manufacturer Narrative

Correction number: 1627487-07262012-002-r.This ipg serial number was included in field advisories.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 rd.; plano, TX 75024 ; 9725264823
• MDR Report Key: 3683372
• MDR Text Key: 4293599
• Report Number: 1627487-2014-21106
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/27/2014

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: 03/01/2011
• Device Model Number: 3788
• Device Lot Number: 773832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2014
• Initial Date FDA Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-12192011-003-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR