FDA Adverse Event Malfunction Summary report: N

INCEPTA

MDR report key: 3771531 · Received April 24, 2014

Report

Report Number: 2124215-2014-08743
Event Type: Malfunction
Date Received: April 24, 2014
Date of Event: January 21, 2014
Report Date: January 21, 2014
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

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 HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED WHEN A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS CONNECTED TO THE RIGHT VENTRICULAR (RV) LEAD DURING A REPLACEMENT PROCEDURE. THE PHYSICIAN CHECKED THE CONNECTION SEVERAL TIMES AND RECONNECTED THE PATIENT¿S OLD DEVICE TO ENSURE THAT THE LEAD WAS NOT DAMAGED DURING THE PROCEDURE. THIS TIME, SHOCK IMPEDANCE MEASUREMENTS WERE IN RANGE. THE PHYSICIAN THOUGHT THERE MIGHT BE AN ISSUE WITH THE NEW DEVICE AND DECIDED TO REPLACE IT WITH ANOTHER CRT-D BUT AGAIN, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS WERE NOTED. A SYNCHRONIZED SHOCK WAS DELIVERED AT 1.1 JOULES WHICH PRODUCED A SHOCK IMPEDANCE MEASUREMENT OF MORE THAN 125 OHMS. IT WAS SUSPECTED THAT THERE WAS AN ISSUE WITH THE RV COIL AND THE LEAD WAS SURGICALLY ABANDONED AND REPLACED WITH NORMAL MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE FIRST CRT-D IS NO LONGER IN SERVICE WHILE THE SECOND CRT-D REMAINS IN SERVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
248657	INCEPTA	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	P165

Patients

Seq	Age	Sex	Outcome	Treatment
1	50 YR			P106\| 0181\| 0166\| P165\| 4525\| 5076