FDA Adverse Event Injury Summary report: N

EON MINI

MDR report key: 3850514 · Received May 30, 2014

Report

Report Number: 1627487-2014-01360
Event Type: Injury
Date Received: May 30, 2014
Date of Event: May 7, 2014
Report Date: May 7, 2014
Manufacturer: ST JUDE MEDICAL - NEUROMODULATION
Product Code: GZB
PMA / PMN Number: P010032
Removal / Correction Number: 1627487-07262012-002-R
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

CORRECTION/REMOVAL NUMBER: 1627487-12192011-003-R AND 1627487-07262012-001-C. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES AND A FIELD CORRECTION. SJM HAS LIMITED INFO 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. REF MFR REPORT #1627487-2014-01361. IT WAS REPORTED THE PT EXPERIENCES UNCOMFORTABLE POCKET HEATING WHILE RECHARGING. REPORTEDLY, THERE'S NO CONFIRMED SKIN IRRITATION. THE PT WAS ADVISED ON CHARGING TECHNIQUES AND USAGE OF THE CHARGING BELT. A REPLACEMENT CHARGER WAS SENT. F/U IDENTIFIED THE REPLACEMENT CHARGER IS WORKING PROPERLY AND RESOLVED THE ISSUE. ON 08/01/2012 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
319762	EON MINI	SCS IPG	GZB	ST JUDE MEDICAL - NEUROMODULATION	3788	3203789

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Other	IMPLANT DATE:\| SCS ANCHOR: MODEL 1194\| IMPLANT DATE:\| SCS LEAD: MODEL 3228