CONSULTA CRT-D

MDR report key: 3861636 · Received June 10, 2014

Report

Report Number: 3004209178-2014-11170
Event Type: Injury
Date Received: June 10, 2014
Date of Event: March 7, 2014
Report Date: March 7, 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: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

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: 419688 LEAD IMPLANTED: (B)(6) 2011; 559445 LEAD IMPLANTED: (B)(6) 2011. (B)(4).

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 IS SUSPECTED OF EARLY BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. HOWEVER, POST GENERATOR CHANGE PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD WAS READING HIGH IMPEDANCE. THE POCKET WAS REOPENED AND IT WAS FOUND THAT THE SETSCREW ON THE HEADER OF THE DEVICE FOR THE LV LEAD WAS LOOSE. THE SETSCREW WAS TIGHTENED AND THE ISSUE WAS RESOLVED. THE REPLACEMENT DEVICE AND LV LEAD REMAIN 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
341490	CONSULTA CRT-D	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO	NIK	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	D224TRK

Patients

Seq	Age	Sex	Outcome	Treatment
1	00080 YR		Hospitalization\| R	6944-58 LEAD