FDA Adverse Event Malfunction Summary report: N

ACUITY

MDR report key: 3955857 · Received July 24, 2014

Report

Report Number: 2124215-2014-14421
Event Type: Malfunction
Date Received: July 24, 2014
Date of Event: June 24, 2014
Report Date: June 25, 2014
Manufacturer: CPI - DEL CARIBE
Product Code: OJX
PMA / PMN Number: P050046
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE CLINIC CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AS THEY RECEIVED AN ALERT THAT THIS PATIENT¿S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS DEACTIVATED AND WANTED TO LET US KNOW THAT THE DEACTIVATION WAS INTENTIONAL AS THE PATIENT WAS DNR STATUS. THE CLINIC ALSO STATED THEY WERE GOING TO SCHEDULE AN IN-OFFICE DEVICE CHECK WITH THE PATIENT AS AN OUT OF RANGE LEFT VENTRICULAR (LV) PACING IMPEDANCE WAS OBSERVED, HOWEVER WAS THEN INFORMED THE PATIENT HAD PASSED AWAY THE FOLLOWING MORNING. THE DEVICE DEACTIVATION OCCURRED ON (B)(6) 2014 AT 16:44 PM AND THE OUT OF RANGE LV IMPEDANCE RECORDED THAT SAME DAY, BUT AT 19:55 PM, THEN THE PATIENT DIED THE MORNING OF (B)(6). THE CAUSE OF THE OUT OF RANGE LV LEAD IMPEDANCE WAS NOT DETERMINED, HOWEVER THE FIELD REPRESENTATIVE WAS CONTACTED AND CONFIRMED THAT NO ALLEGATIONS HAVE BEEN MADE AGAINST ANY OF THE BOSTON SCIENTIFIC PRODUCTS. THE FIELD REPRESENTATIVE WAS UNABLE TO PROVIDE ANY FURTHER INFORMATION AS THIS CLINIC DOES THEIR OWN DEVICE CHECKS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
433763	ACUITY	IMPLANTABLE LEAD	OJX	CPI - DEL CARIBE	4555

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR			4469\| N119\| 4555\| 0184