FDA Adverse Event Injury Summary report: N

EON MINI IPG, 16-CHANNEL RECHARGEABLE

MDR report key: 2041155 · Received March 29, 2011

Report

Report Number: 1627487-2011-00414
Event Type: Injury
Date Received: March 29, 2011
Date of Event: February 28, 2011
Report Date: February 28, 2011
Manufacturer: ST JUDE MEDICAL- NEUROMODULATION DIVISION
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

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 4. REFERENCE MFR REPORT #S: 1627487-2011-00415, 1627487-2011-00416 AND 1627487-2011-00417. THE PT REC'D HER SCS SYSTEM ON (B)(6) 2010 CONSISTING OF AN IPG, TWO PERCUTANEOUS LEADS AND TWO LEAD ANCHORS. THE PT'S ORIGINAL LEADS WERE REPLACED ON (B)(6) 2010 DUE TO ALLEGATIONS OF OVERSTIMULATION (SEE MFR REPORT# 1627487-2010-01086). IT WAS REPORTED THAT THE PT WAS RECEIVING INTERMITTENT STIMULATION AT THE IPG POCKET SITE. DIAGNOSTIC TEST REVEALED LOW IMPEDANCE READINGS FOR ALL LEAD CONTACTS. AN X-RAY WAS TAKEN FOR FURTHER INTERROGATION; HOWEVER, NO VISIBLE ANOMALIES WERE REPORTED. THE PT'S SCS SYSTEM WAS SUBSEQUENTLY EXPLANTED AS SHE IS SEEKING ALTERNATIVE TREATMENT OPTIONS FOR HER PAIN ISSUES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EON MINI IPG, 16-CHANNEL RECHARGEABLE	TOTALLY IMPLANTABLE PULSE GENERATOR	LGW	ST JUDE MEDICAL- NEUROMODULATION DIVISION	3788	2880336

Patients

Seq	Age	Sex	Outcome	Treatment
1	25 YR		Required Intervention