FDA Adverse Event Injury Summary report: N

EON MINI

MDR report key: 2921636 · Received January 10, 2013

Report

Report Number: 1627487-2013-02073
Event Type: Injury
Date Received: January 10, 2013
Date of Event: December 21, 2012
Report Date: December 21, 2012
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: LGW
PMA / PMN Number: P010032
Removal / Correction Number: 1627487-07262012-001-C
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

CORRECITON/REMOVAL NUMBERS: 1627487-05242011-002-R, 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION AND 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.

Description of Event or Problem · 1

DEVICE 1 OF 2. REF MFR REPORT: 1627487-2013-02074. IT WAS REPORTED THE PT EXPERIENCES POCKET HEATING WHILE CHARGING HIS IPG. HE REPORTED IF HE CHARGES FOR MORE THAN AN HOUR HIS SKIN GETS RED AND HE FEELS A BURNING SENSATION AT THE IPG SITE. THE SJM REP ADVISED THE PT OF CHARGING PRECAUTIONS AND A NEW CHARGING SYSTEM WAS SENT TO THE PT. FOLLOW-UP INDICATED THE PT DID NOT EXPERIENCE THE ISSUES WITH THE NEW CHARGER. 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
13996	EON MINI	SCS IPG	LGW	ST. JUDE MEDICAL - NEUROMODULATION	3788	2864598

Patients

Seq	Age	Sex	Outcome	Treatment
1	47 YR		Required Intervention	SCS LEAD, MODEL 3288\| IMPLANT DATE: