FDA Adverse Event Injury Summary report: N

EON IMPLANTABLE PULSE GENERATOR

MDR report key: 2003873 · Received February 24, 2011

Report

Report Number: 1627487-2011-02236
Event Type: Injury
Date Received: February 24, 2011
Date of Event: January 29, 2011
Report Date: January 29, 2011
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UT, 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

THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2007. IT WAS REPORTED THE PATIENT CAN NO LONGER ESTABLISH TELEMETRY BETWEEN HER IPG AND CHARGING SYSTEM. A NEW CHARGING SYSTEM WAS SENT TO THE PATIENT BUT THE REPLACEMENT CHARGING SYSTEM WAS NOT ABLE TO CORRECT THE ISSUE. AS THE PATIENT ALSO REPORTED PAIN AT THE IPG POCKET, A X-RAY OF THE SCS SYSTEM WAS TAKEN. THE X-RAY REVEALED NORMAL PLACEMENT OF THE IPG WITH NORMAL STRESS RELIEF LOOPS. NO MISALIGNMENT OR DISCONNECTIONS IN THE HEADER WERE OBSERVED. DUE TO THE PATIENT'S INABILITY TO CHARGE THE IPG, SHE IS CURRENTLY WITHOUT STIMULATION. THE IPG WAS EXPLANTED AND REPLACED. THE EXPLANTED IPG WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS, HOWEVER, ANALYSIS IS CURRENTLY IN PROCESS. FOLLOW UP ON THE PATIENT FOUND NO FURTHER ISSUES REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EON IMPLANTABLE PULSE GENERATOR	TOTALLY IMPLANTABLE PULSE GENERATOR	LGW	ST. JUDE MEDICAL - NEUROMODULATION	3716	64043

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention