FDA Adverse Event Malfunction Summary report: N

CARELINK

MDR report key: 4163192 · Received October 10, 2014

Report

Report Number: 2182208-2014-03003
Event Type: Malfunction
Date Received: October 10, 2014
Date of Event: August 19, 2014
Report Date: August 19, 2014
Manufacturer: MEDTRONIC, INC.
Product Code: KRG
PMA / PMN Number: P890003
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 229047, SOFTWARE ANALYZER. (B)(4).

Additional Manufacturer Narrative · 1

CORRECTED INFORMATION NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: ANALYSIS WAS UNABLE TO REPLICATE THE CUSTOMER EXPERIENCE OF POWERING ON TO AN ERROR MESSAGE HOWEVER A SYSTEM ERROR WAS FOUND IN THE ERROR LOG AND THEREFORE THE HARD DRIVE WAS REIMAGED AND THE SOFTWARE RELOADED. ANALYSIS ALSO FOUND THAT THE SYSTEM FAN AND HARD DRIVE WERE NOISY AND THAT THE ELECTROCARDIOGRAM CONNECTOR ON THE LINK ELECTRONIC MODULE (LEM) BOARD WAS LOOSE. THE HARD DRIVE, SYSTEM FAN AND LEM BOARD WERE REPLACED AND THE LEM BOARD CALIBRATED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PROGRAMMER POWERED ON TO AN ERROR MESSAGE. RUNNING THE SERVICE DISK SEVERAL TIMES AND CYCLING THE POWER DID NOT RESOLVE THE SITUATION. IT WAS FURTHER REQUESTED THAT THE PROGRAMMER RECEIVE A TEST AND CALIBRATION. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
644468	CARELINK	PROGRAMMER, PACEMAKER	KRG	MEDTRONIC, INC.	2090W

Patients

Seq	Age	Sex	Outcome	Treatment
1				2067 RADIOFREQUENCY PROGRAMMER HEAD