CARELINK PROGRAM W/TELEMETRY C

Report

Report Number: 2182208-2013-00077
Event Type: Malfunction
Date Received: February 9, 2013
Date of Event: November 14, 2012
Report Date: November 14, 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: OTHER

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 COULD NOT CONFIRM THE REPORTED EVENT, HOWEVER, THE LINK ELECTRONIC MODULE (LEM) CIRCUIT BOARD WAS REPLACED AND CALIBRATED. IT WAS ALSO NOTED THAT THE DEVICE FAN RUNS BUT THE SCREEN REMAINS BLANK, AND THE PRINTER INTERMITTENTLY MADE NOISE WHEN PRINTING. PRODUCT ID 2067. (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 THERE WAS ECG (ELECTROCARDIOGRAM) NOISE AND TELEMETRY FAILURE. THE PROGRAMMER AND PROGRAMMER RF (RADIO-FREQUENCY) HEAD WERE RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THERE WAS ECG (ELECTROCARDIOGRAM) NOISE AND TELEMETRY FAILURE. THE PROGRAMMER AND PROGRAMMER RF (RADIO-FREQUENCY) HEAD WERE RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
57845	CARELINK PROGRAM W/TELEMETRY C	PULSE-GENERATOR, PACEMAKER, IMPLANTABLE	DXY	RICE CREEK MFG	2090

Patients

Seq	Age	Sex	Outcome	Treatment
1				2067 PROGRAMMER RF (RADIO-FREQUENCY) HEAD