FDA Adverse Event Injury Summary report: N

EON MINI

MDR report key: 3141916 · Received May 28, 2013

Report

Report Number: 1627487-2013-03721
Event Type: Injury
Date Received: May 28, 2013
Date of Event: May 3, 2013
Report Date: May 3, 2013
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: LGW
PMA / PMN Number: P010032
Removal / Correction Number: 1627487-12192011-003-R,
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

A 1627487-07262012-002-R, 1627487-07262012-001-C. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES AND A FIELD CORRECTION. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-03722. THE PT REPORTED EXPERIENCING UNCOMFORTABLE HEATING AND A HOT BURNING SENSATION WHILE CHARGING. THE PT USES THE CHARGING POUCH AND ENSURES DIRECT PLACEMENT OF THE CHARGING SYSTEM ANTENNA OVER THE SCS IPG. THE PT ALSO REPORTED CHARGING WITHOUT STIMULATION; HOWEVER, THE HEATING STILL OCCURS. SUBSEQUENTLY, A REPLACEMENT CHARGING SYSTEM (LOW ENERGY) HAS BEEN SENT TO THE PT. ON 8/1/2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
233411	EON MINI	SCS IPG	LGW	ST. JUDE MEDICAL - NEUROMODULATION	3788	172891

Patients

Seq	Age	Sex	Outcome	Treatment
1	48 YR		Required Intervention	IMPLANT DATE:\| SCS LEAD: MODEL 3266