FDA Adverse Event Malfunction Summary report: N

CARELINK

MDR report key: 1922296 · Received December 13, 2010

Report

Report Number: 2182208-2010-00946
Event Type: Malfunction
Date Received: December 13, 2010
Manufacturer: MEDTRONIC, INC.
Product Code: DXY
PMA / PMN Number: P890003/S065
Removal / Correction Number: ASKU
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

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) NO ANOMALIES FOUND.

Description of Event or Problem · 1

IT WAS REPORTED THAT PACING WAS SET TO 75, BUT PACING WAS OBSERVED TO BE 120 ON THE DISPLAY. THE RATE WAS CONFIRMED TO BE 75. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT PACING WAS SET TO 75, BUT PACING WAS OBSERVED TO BE 120 ON THE DISPLAY. THE RATE WAS CONFIRMED TO BE 75. THE ANALYZER WAS IMMEDIATELY REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other\| R