FDA Adverse Event Injury Summary report: N

EON MINI

MDR report key: 3961296 · Received July 18, 2014

Report

Report Number: 1627487-2014-03489
Event Type: Injury
Date Received: July 18, 2014
Date of Event: June 24, 2014
Report Date: March 16, 2016
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: GZB
PMA / PMN Number: P010032
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT ALLEGES BURNING PAIN AND SHOCKING AT THE SCS IPG POCKET SITE. IT WAS ALSO REPORTED THE PATIENT ALLEGES "BURN SPOTS" AT THE BACK, FOOT, AND LEG WHEN THE SCS SYSTEM IS NOT IN USE. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUES. ON (B)(4) 2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED. DUE TO THE NATURE OF LITIGATION, THESE ALLEGATIONS CANNOT BE CONFIRMED OR REJECTED. 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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
421163	EON MINI	SCS IPG	GZB	ST. JUDE MEDICAL - NEUROMODULATION	3788	3866015

Patients

Seq	Age	Sex	Outcome	Treatment
1	50 YR		Other	SCS ANCHOR: MODEL 1192(2)\| IMPLANT DATE:\| IMPLANT DATE:\| SCS LEAD: MODEL 3186