FDA Adverse Event Injury Summary report: N

CONCERTO CRT-D DR

MDR report key: 2952840 · Received February 9, 2013

Report

Report Number: 3004209178-2013-01808
Event Type: Injury
Date Received: February 9, 2013
Report Date: November 30, 2012
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: SC, 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. CONCOMITANT PRODUCTS: 3387-40, DEEP BRAIN STIMULATION LEAD, (B)(6) 2005; (B)(4), NEURO EXTENSION, (B)(6) 2005; 7426, DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATOR (IPG), (B)(6) 2005; 5076, IMPLANTABLE PACING LEAD, (B)(6) 2006; 1056T, COMPETITOR IMPLANTABLE PACING LEAD, (B)(6) 2006. (B)(4).

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE MET 82% OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

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 THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND HAD EARLY BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
57781	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	00080 YR		Hospitalization\| R	6947 IMPLANTABLE TACHY LEAD