FDA Adverse Event Injury Summary report: N

EON MINI

MDR report key: 2821162 · Received October 25, 2012

Report

Report Number: 1627487-2012-02581
Event Type: Injury
Date Received: October 25, 2012
Date of Event: July 1, 2012
Report Date: October 3, 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

CORRECTION: 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION AND FIELD ADVISORIES. SJM HAS LIMITED INFORMATION 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: 1627487-2012-02582. IT WAS REPORTED, THE PT HAS FELT HEATING AT HER IPG SITE DURING CHARGING SINCE (B)(6). SHE STATED SHE CHARGES HER IPG EVERY OTHER DAY FOR ABOUT 3 HRS DUE TO HER HIGH PROGRAM SETTINGS. SHE STATED THE WARMING SENSATION IS NOT PAINFUL AND IMPROVES IF SHE CHARGES MORE FREQUENTLY. THE SJM REP ADVISED THE PT OF CHARGING PRECAUTIONS AND REPROGRAMMED THE PT TO SEE IF THE ISSUE IMPROVED. 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
1	EON MINI	SCS IPG	LGW	ST. JUDE MEDICAL - NEUROMODULATION	3788	3190241

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR		Required Intervention	IMPLANT DATE:\| SCS LEAD: MODEL 3228