FDA Adverse Event Malfunction Summary report: N

CARELINK

MDR report key: 3860170 · Received June 10, 2014

Report

Report Number: 2182208-2014-01518
Event Type: Malfunction
Date Received: June 10, 2014
Date of Event: March 11, 2014
Report Date: March 31, 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

THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: DURING ANALYSIS IT WAS DETERMINED THAT THE LENS ON THE UPPER CASE WAS CRACKED AND THE UPPER CASE WAS REPLACED. FURTHER, THE HEAD FAILED UPLINK TESTS AND THEREFORE THE CABLE WAS REPLACED AND THE HEAD LABEL WAS NOTED TO BE MISSING ITS BACK COATING AND THE LABEL WAS REPLACED. PRODUCT ID: 229047 SOFTWARE ANALYZER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT AN ERROR MESSAGE WAS DISPLAYED ON THE PROGRAMMER. THE CALLER RAN THE SERVICE DISK IN AN EFFORT TO CLEAR THE ERROR, HOWEVER, THE SERVICE DISK KEPT REPEATING THE SERVICE PROCESS OVER AND OVER AGAIN. TECHNICAL SUPPORT (TS) HAD THE CALLER INSERT THE SERVICE DISK, CYCLE POWER AND FOLLOWED DIRECTIONS GIVEN FROM THE SOFTWARE DEVELOPMENT TEAM. HOWEVER, THE SAME BEHAVIOR WAS OBSERVED. THE PROGRAMMER HAS BEEN RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE RADIOFREQUENCY PROGRAMMER HEAD ORIGINALLY RETURNED AS AN ASSOCIATED DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
338717	CARELINK	PROGRAMMER, PACEMAKER	KRG	MEDTRONIC, INC.	2067L

Patients

Seq	Age	Sex	Outcome	Treatment
1				2090 PROGRAMMER