FDA Adverse Event Injury Summary report: N

CONCERTO CRT-D DR

MDR report key: 3993686 · Received August 8, 2014

Report

Report Number: 3004209178-2014-14596
Event Type: Injury
Date Received: August 8, 2014
Date of Event: May 16, 2014
Report Date: May 19, 2014
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: NIK
PMA / PMN Number: P010031
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: NURSE

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. CONCOMITANT PRODUCTS: 419378 LEAD, IMPLANTED (B)(6) 2004. (B)(4).

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: THE ACTUAL PRODUCT WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND WAS ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED AN ALERT FOR EXCESSIVE CHARGE TIME END OF SERVICE (EOS). EXCESSIVE CHARGE TIME WARNING OCCURRED ON (B)(6) 2014 FOR A CHARGE TIME OF 16.4 SECONDS.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A LONG CHARGE TIME CAUSED SUDDEN UNEXPECTED TRIGGER OF END OF SERVICE (EOS) STATUS ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE. THE DEVICE WAS EXPLANTED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
467174	CONCERTO CRT-D DR	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO	NIK	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	C154DWK

Patients

Seq	Age	Sex	Outcome	Treatment
1	00068 YR		Hospitalization\| R	694765 LEAD