FDA Adverse Event Malfunction Summary report: N

S-ICD SYSTEM

MDR report key: 3901963 · Received May 7, 2014

Report

Report Number: 3009448963-2014-00051
Event Type: Malfunction
Date Received: May 7, 2014
Date of Event: February 27, 2014
Report Date: April 9, 2014
Manufacturer: CAMERON HEALTH INC
Product Code: NVY
PMA / PMN Number: P11042
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
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 SEVERAL HOURS FOLLOWING THE IMPLANT OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM, THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK. THE DEVICE WAS INTERROGATED AND REVEALED THAT THERE WAS A SUDDEN AND DRAMATIC LOSS OF SIGNAL WITH OVERSENSING THAT CAUSED THE SHOCK. DATA AND X-RAYS WERE SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICE (TS) FOR REVIEW. NO ANOMALIES WERE NOTED WITH THE IMPLANTED SYSTEM THROUGH THE X-RAYS AND THE CURRENT VECTOR SET UP WAS APPROPRIATE. IT IS SUSPECTED THAT THERE WAS A POSSIBLE AIR BUBBLE AT THE XIPHOID INCISION SITE. ANOTHER SET OF X-RAYS WERE TAKEN AND IT WAS CONFIRMED THAT THERE WAS AIR AROUND THE ELECTRODE AT THE XIPHOID INCISION, BUT IT APPEARED TO BE DISSIPATING. TESTING WAS PERFORMED AND WAS UNABLE TO REPRODUCE THE SIGNALS THAT WERE OVERSENSED PREVIOUSLY. X-RAYS WERE TAKEN AGAIN SEVERAL DAYS LATER AND SHOWED THAT THE AIR HAD FULLY DISSIPATED. THE PATIENT WAS THEN DISCHARGED FROM THE HOSPITAL. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND ELECTRODE REMAIN IMPLANTED AND IN SERVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
276762	S-ICD SYSTEM	IMPLANTABLE LEAD	NVY	CAMERON HEALTH INC	3010

Patients

Seq	Age	Sex	Outcome	Treatment
1	20 YR			1010