RELIA DR

Report

Report Number: 6000094-2012-02407
Event Type: Injury
Date Received: October 31, 2012
Date of Event: May 7, 2012
Manufacturer: IPG MFG SWITZERLAND
Product Code: NVZ
PMA / PMN Number: P980035/S097
Removal / Correction Number: Z-2120-2011
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PL
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: PRODUCT PERFORMANCE DATA WAS RECEIVED, ANALYZED, AND NO ANOMALIES WERE FOUND.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS AND THAT A LOSS OF CAPTURE WAS NOTED IN THE VENTRICULAR CHANNEL WHILE THE DEVICE WAS PROGRAMMED TO ADAPTIVE CAPTURE MANAGEMENT. IT WAS ALSO REPORTED THAT THE PATIENT HAS A HISTORY OF COMPLETE HEART BLOCK. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS AND THAT A LOSS OF CAPTURE WAS NOTED IN THE VENTRICULAR CHANNEL WHILE THE DEVICE WAS PROGRAMMED TO ADAPTIVE CAPTURE MANAGEMENT. IT WAS ALSO REPORTED THAT THE PATIENT HAS A HISTORY OF COMPLETE HEART BLOCK. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RELIA DR	PULSE GENERATOR, PERMANENT, IMPLANTABLE	NVZ	IPG MFG SWITZERLAND	REDR01

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| L\| R