FDA Adverse Event Injury Summary report: N

EON MINI

MDR report key: 2993972 · Received March 1, 2013

Report

Report Number: 1627487-2013-12278
Event Type: Injury
Date Received: March 1, 2013
Date of Event: February 7, 2013
Report Date: February 7, 2013
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: LGW
PMA / PMN Number: P010032
Removal / Correction Number: 1627487-05242011-002-R
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

CORRECTION: 1627487-07262012-002-R AND 1627487-07262012-001-C. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY AND A FIELD CORRECTION. 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 # 1627487-2013-12279. IT WAS REPORTED, THE PT HAS NOT BEEN USING THE SYSTEM DUE TO POCKET HEATING WHILE CHARGING. THE PT WAS GIVEN A NEW LE CHARGER. IT WAS ALSO REPORTED, THE PT'S PHYSICIAN IS REQUESTING AN EXPLANT OF THE SYSTEM DUE TO THE NEED FOR AN MRI. 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
88755	EON MINI	SCS IPG	LGW	ST. JUDE MEDICAL - NEUROMODULATION	3788	2807433

Patients

Seq	Age	Sex	Outcome	Treatment
1	34 YR		Required Intervention	IMPLANT DATE:\| IMPLANT DATE:\| IMPLANT DATE:\| SCS LEAD: MODEL 3189 (2)\| SCS LEAD: MODEL 3166\| SCS ANCHORS: MODEL 1194 (2)