PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Report

Report Number: 2182208-2013-00059
Event Type: Malfunction
Date Received: February 9, 2013
Date of Event: November 1, 2012
Report Date: November 1, 2012
Manufacturer: RICE CREEK MFG
Product Code: DXY
PMA / PMN Number: P890003/S080
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: SERVICE PERSONNEL

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE DEVICE HAD A SYSTEM ERROR. AS A RESULT THE LINK ELECTRONIC MODULE (LEM) CIRCUIT BOARD WAS REPLACED. (B)(4).

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED A SYSTEM ERROR OCCURRED. IT WAS FURTHER REPORTED THE ERROR OCCURRED DURING THE READ OPERATION (TELEMETRY) OF THE DEVICE. THE PROGRAMMER WAS RETURNED FOR REPAIR AND CALIBRATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED A SYSTEM ERROR OCCURRED. IT WAS FURTHER REPORTED THE ERROR OCCURRED DURING THE READ OPERATION (TELEMETRY) OF THE DEVICE. THE PROGRAMMER WAS RETURNED FOR REPAIR AND CALIBRATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
56545		PULSE-GENERATOR, PACEMAKER, IMPLANTABLE	DXY	RICE CREEK MFG	2090

Patients

Seq	Age	Sex	Outcome	Treatment
1