FDA Adverse Event Malfunction Summary report: N

S-ICD SYSTEM

MDR report key: 4605936 · Received March 11, 2015

Report

Report Number: 3009448963-2015-00111
Event Type: Malfunction
Date Received: March 11, 2015
Date of Event: August 25, 2014
Report Date: February 11, 2015
Manufacturer: CAMERON HEALTH INC.
Product Code: LWS
PMA / PMN Number: P11042
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

AS NO FURTHER INFO CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFO BE PROVIDED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFO THAT THIS LOCAL REP CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS). ACCORDING TO THE LOCAL REP, THIS PT WAS SEEN FOLLOWING DELIVERY OF AN INAPPROPRIATE SHOCK FROM THE DEVICE. SHOCK DELIVERY OCCURRED WHILE THE PT WAS PUTTING BOOTS ON. THE DEVICE HAD BEEN PROGRAMMED TO ALTERNATE VECTOR AND THE R-WAVES BECOME DIMINISHED WHEN SHOCK DELIVERY OCCURRED. THE LOCAL REP WAS ABLE TO REPRODUCE THE CLINICAL OBSERVATION BY HAVING THE PT BEND OVER AND MIMIC THE ACTION OF PUTTING BOOTS ON. THE VECTOR WAS REPROGRAMMED TO PRIMARY IX AS THE R WAVES DID NOT DIMINISH. STORED DATA WAS UPLOADED AND IS AVAILABLE FOR REVIEW BY IN HOUSE ENGINEERING. A REVIEW OF THE TREATED EPISODE FOUND THAT THE R-WAVE HAD DIMINISHED IN SIZE AND WAS BEING DOUBLE COUNTED (INTRINSIC RATE IN THE 80-90 BPM RANGE). THE MEASURED SHOCK IMPEDANCE FOLLOWING SHOCK DELIVERY WAS 46 OHMS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
166587	S-ICD SYSTEM		LWS	CAMERON HEALTH INC.	1010

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR			3010