FDA Adverse Event Malfunction Summary report: N

CARELINK

MDR report key: 2791302 · Received October 15, 2012

Report

Report Number: 2182208-2012-03355
Event Type: Malfunction
Date Received: October 15, 2012
Date of Event: August 27, 2012
Manufacturer: MEDTRONIC, INC.
Product Code: DXY
PMA / PMN Number: P890003/S065
Adverse Event: Yes
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.

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. ANALYZER PASSED ALL FUNCTIONAL AND SYSTEMS TESTS. (B)(4) PROGRAMMER PASSED ALL FUNCTIONAL AND SYSTEM TESTS. (B)(4) UNABLE TO INTERROGATE; RF (RADIO FREQUENCY) HEAD CABLE FOUND OUT OF ELECTRICAL SPECIFICATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN IMPLANT CASE, THE ANALYZER WAS NOT SENSING, HAD LOW IMPEDANCE AND HIGH THRESHOLDS. THE ANALYZER AND PROGRAMMER WERE RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO IMPACT TO THE PATIENT AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN IMPLANT CASE THE ANALYZER WAS NOT SENSING, HAD LOW IMPEDANCE AND HIGH THRESHOLDS. THE ANALYZER AND PROGRAMMER WERE RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO IMPACT TO THE PATIENT AS A RESULT OF THIS EVENT. THE RF (RADIO FREQUENCY) HEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CARELINK	PACING SYSTEM ANALYZER	DXY	MEDTRONIC, INC.	2290

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other	2067L PROGRAMMER RF HEAD