FDA Adverse Event Injury Summary report: N

EON MINI

MDR report key: 2791995 · Received October 12, 2012

Report

Report Number: 1627487-2012-12267
Event Type: Injury
Date Received: October 12, 2012
Date of Event: September 19, 2012
Report Date: September 19, 2012
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: LGW
PMA / PMN Number: P010032
Removal / Correction Number: 1627487-05242011-002-R
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

CORRECTION: THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES AND A FIELD CORRECTION; 1627487-07262012-002-R, 1627487-07262012-001-C. 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

DEVICE 1 OF 2. REFERENCE MFR REPORT #1627487-2012-12268. THE PATIENT REPORTED CHARGING FOR ABOUT 30 MINUTES WHILE SLEEPING AND SUDDENLY FELT A HEATING SENSATION AROUND THE NECK. THE SJM REPRESENTATIVE ADVISED THE PATIENT TO USE THE ANTENNA POUCH AND TO STAY ALERT WHEN CHARGING. THE PATIENT THEN REPORTED DROPPING THE CHARGER AND IT CRACKED. FOLLOW UP DETERMINED THE PATIENT WAS SENT A NEW CHARGER. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENTS 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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EON MINI	SCS IPG	LGW	ST. JUDE MEDICAL - NEUROMODULATION	3788	13766053

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR		Required Intervention	IMPLANT:\| SCS EXT: MODEL 3386(2)\| SCS LEAD: MODEL 3219\| IMPLANT: