CARELINK

Report

Report Number: 2182208-2013-00095
Event Type: Malfunction
Date Received: February 9, 2013
Date of Event: November 12, 2012
Report Date: November 12, 2012
Manufacturer: RICE CREEK MFG
Product Code: DXY
PMA / PMN Number: P890003/S065
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: THE DEVICE WAS ANALYZED AND NO ANOMALIES WERE FOUND. (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).

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THERE WAS TELEMETRY FAILURE. IT WAS ALSO REPORTED AN ERROR OCCURRED. THE PROGRAMMER AND RF (RADIO FREQUENCY) TELEMETRY HEAD WERE 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 THERE WAS TELEMETRY FAILURE. IT WAS ALSO REPORTED AN ERROR OCCURRED. THE PROGRAMMER AND RF (RADIO FREQUENCY) TELEMETRY HEAD WERE 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
56184	CARELINK	PULSE-GENERATOR, PACEMAKER, IMPLANTABLE	DXY	RICE CREEK MFG	2067

Patients

Seq	Age	Sex	Outcome	Treatment
1				2090W PROGRAMMER