FDA Adverse Event Injury Summary report: N

EON MINI

MDR report key: 3133125 · Received May 20, 2013

Report

Report Number: 1627487-2013-03684
Event Type: Injury
Date Received: May 20, 2013
Date of Event: April 25, 2013
Report Date: April 25, 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 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: 1627487-2013-03687. IT WAS REPORTED THE PATIENT WAS SCHEDULED FOR A SCS IPG POCKET SITE REVISION TO IMPLANT THE IPG DEEPER; HOWEVER, BEFORE THE PROCEDURE THE PATIENT STATED HE WAS EXPERIENCING RESIDUAL STIMULATION WHEN HIS SCS SYSTEM WAS TURNED OFF. THE PATIENT ALSO STATED HE WAS EXPERIENCING TINGLING IN HIS FINGERS. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO REPLACE THE IPG. ADDITIONALLY, DIAGNOSTICS SHOWED THE IPG HAD FLUID INTRUSION. THE PATIENT RECEIVED EFFECTIVE STIMULATION POST-OPERATIVELY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
222935	EON MINI	SCS IPG	LGW	ST. JUDE MEDICAL - NEUROMODULATION	3788	3878226

Patients

Seq	Age	Sex	Outcome	Treatment
1	47 YR		Required Intervention