FDA Adverse Event Malfunction Summary report: N

EON IMPLANTABLE PULSE GENERATOR

MDR report key: 1870697 · Received September 29, 2010

Report

Report Number: 1627487-2010-02270
Event Type: Malfunction
Date Received: September 29, 2010
Date of Event: May 13, 2009
Report Date: May 13, 2009
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS
Product Code: LGW
PMA / PMN Number: P010032
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVALUATION: METHOD: - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: - THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: - THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FORM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. (B)(4). ANS 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. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

DEVICE 2 OF 2. REFERENCE MANUFACTURER'S REPORT 1627487-2010-02272. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2007. IT WAS REPORTED THAT THE PT WAS INSTRUCTED TO PASS THROUGH A METAL DETECTOR AT A COURT HOUSE. AFTER PASSING THROUGH THE METAL DETECTOR, THE PT LOST STIMULATION. THE SYSTEM WAS EVALUATED AND FOUND TO GIVE HIGH IMPEDANCE READINGS. THE LEAD AND IPG WERE EXPLANTED AND REPLACED ON (B)(6) 2009. THE SYSTEM WAS NOT RETURNED TO ANS FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EON IMPLANTABLE PULSE GENERATOR	TOTALLY IMPLANTABLE PULSE GENERATOR	LGW	ADVANCED NEUROMODULATION SYSTEMS	3716	6707

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention