FDA Adverse Event Injury Summary report: N

CONCERTO CRT-D DR

MDR report key: 2813070 · Received October 31, 2012

Report

Report Number: 6000144-2012-06573
Event Type: Injury
Date Received: October 31, 2012
Manufacturer: MEDTRONIC MED REL, INC.
Product Code: NIK
PMA / PMN Number: P010031/S031
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: PHYSICIAN

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. RESISTANCE/IMPEDANCE INCREASE WAS NOTED AS TWO PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(4)-2011 02:15:04 AND (B)(4)-2012 02:15:04. THE WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOW HIGH IMPEDANCE FOR MIN AND MAX RV PACE FROM 2208 TO 2480 OHMS RANGE BETWEEN (B)(4)-2011 AND (B)(4)-2012.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A "HOT FEELING" ON THE BOTTOM EDGE OF THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR A SECOND OR MORE ABOUT 3-4 TIMES A MONTH. THE HOT FEELING OCCURS AT NO CONSISTENT TIME OF DAY. THE DEVICE WILL BE REPLACED SOON AS THE DEVICE IS APPROACHING ELECTIVE REPLACEMENT INDICATOR, BUT CURRENTLY IT REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CONCERTO CRT-D DR	IMPLANTABLE PACEMAKER/CARDIO/DEFIB	NIK	MEDTRONIC MED REL, INC.	C154DWK

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Hospitalization\| R	4195 IMPLANTABLE PACING LEAD\| 4524 IMPLANTABLE PACING LEAD\| 0144 COMPETITOR IMPLANTABLE TACHY LEAD