FDA Adverse Event Injury Summary report: N

EON RECHARGEABLE IPG

MDR report key: 2051349 · Received April 7, 2011

Report

Report Number: 1627487-2011-01363
Event Type: Injury
Date Received: April 7, 2011
Date of Event: March 9, 2011
Report Date: March 10, 2011
Manufacturer: ST JUDE MEDICAL - NEUROMODULATION DIVISION
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

SJM HAS LIMITED INFO 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

THE PT REC'D HIS SCS SYS, INCLUDING AN IPG, ON (B)(6) 2009. IT WAS REPORTED THAT THE PT FELT A HEATING SENSATION AT HIS IPG POCKET SITE. HE STATED THAT THE ONLY FEELS THIS WHEN THE STIMULATION IS ON AND NOT WHEN HE IS CHARGING THE IPG; HE KEEPS THE STIMULATION OFF WHEN CHARGING. HE REPORTED THAT HE USES THE STIMULATION FOR APPROX SEVEN DAYS IN A ROW AND THEN TURNS THE STIMULATION OFF FOR ONE DAY. HOWEVER, HE STATED THAT HE FEELS A RESIDUAL HEATING SENSATION WITH THE STIMULATION OFF, BUT THE SENSATION GRADUALLY DECREASES THEN CEASES OVER THE COURSE OF THE DAY. DURING A REPROGRAMMING SESSION, ADJUSTMENTS WERE MADE ON THE AMPLITUDE LEVEL OF THE PT'S PROGRAMS. F/U ON THE PT FOUND THAT HE HAS NOT FELT THE HEATING SENSATION AT THE IPG SITE SINCE HE WAS REPROGRAMMED . HE STATED HE FELT EFFECTIVE STIMULATION, AND NO FURTHER PT COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EON RECHARGEABLE IPG	TOTALLY IMPLANTABLE PULSE GENERATOR	LGW	ST JUDE MEDICAL - NEUROMODULATION DIVISION	3716	171490

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention