FDA Adverse Event Injury Summary report: N

EON MINI

MDR report key: 3150043 · Received May 30, 2013

Report

Report Number: 1627487-2013-15712
Event Type: Injury
Date Received: May 30, 2013
Date of Event: May 4, 2013
Report Date: May 7, 2013
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

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: 1627487-2013-15713. THE PT HAS 2 LEADS (FROM THE SAME LOT) IMPLANTED AS PART OF HIS SCS SYSTEM. IT WAS REPORTED THE PT IS UNABLE TO COMMUNICATE WITH OR CHARGE HIS IPG. ADDITIONALLY, A COMMUNICATION ERROR MASSAGE APPEARED ON THE PROGRAMMER. THE SJM REPRESENTATIVE MET WITH THE PT AND CONFIRMED THE ISSUE. THE PT STATED HE HAS NOT CHARGED HIS IPG IN APPROXIMATELY 45 DAYS. FOLLOW-UP INFORMATION INDICATED THE X-RAYS WERE TAKEN AND REVEALED THE LEADS HAD MIGRATED. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
238012	EON MINI	SCS IPG	LGW	ST. JUDE MEDICAL - NEUROMODULATION	3788	3552200

Patients

Seq	Age	Sex	Outcome	Treatment
1	30 YR		Required Intervention	IMPLANT DATE:\| SCS ANCHOR: MODEL: 1192 (2)