FDA Adverse Event Malfunction Summary report: N

CONSULTA

MDR report key: 1922404 · Received December 13, 2010

Report

Report Number: 6000144-2010-05940
Event Type: Malfunction
Date Received: December 13, 2010
Manufacturer: MEDTRONIC MED REL, INC.
Product Code: NIK
PMA / PMN Number: P010031/S084
Removal / Correction Number: ASKU
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. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS INDICATES A MEASURING PROBLEM. DIAGNOSTIC TREND DATA WAS MISSING BETWEEN (B)(6) 2009 AND (B)(6) 2010 AND ON VF EPISODE #5 WAS LISTED AS "DETECTED EPISODE DATA IS INVALID ON (B)(6) 2010". THE DIAGNOSTIC INFORMATION IS CONSISTENT WITH THE EVENT.

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THE DEVICE STORED DATA WAS INVALID, AND COULD NOT BE ACCESSED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CONSULTA	IMPLANTABLE PACEMAKER/CARDIO/DEFIB	NIK	MEDTRONIC MED REL, INC.	D224TRK	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR		Other	4193 IMPLANTABLE PACING LEAD\| 6725 ADAPTOR\| 5076 IMPLANTABLE PACING LEAD\| 5076 IMPLANTABLE PACING LEAD\| 4193 IMPLANTABLE PACING LEAD\| 6947 IMPLANTABLE TACHY LEAD\| 6947 IMPLANTABLE TACHY LEAD\| 6725 ADAPTOR