FDA Adverse Event Injury Summary report: N

S-ICD SYSTEM

MDR report key: 3850578 · Received May 22, 2014

Report

Report Number: 3009448963-2014-00091
Event Type: Injury
Date Received: May 22, 2014
Date of Event: April 21, 2014
Report Date: April 28, 2014
Manufacturer: CAMERON HEALTH
Product Code: NVY
PMA / PMN Number: P11042
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, 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 PATIENT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM WAS SEEN IN CLINIC AFTER RECEIVING MULTIPLE SHOCKS. INITIALLY THERE WAS AN ISSUE INTERROGATING THE DEVICE. IT WAS DETERMINED THAT THE PROGRAMMER WAND WAS NOT IN THE IDEAL LOCATION, AND ONCE IT WAS REPOSITIONED THE INTERROGATION WAS PERFORMED WITHOUT ISSUE. REVIEW OF DATA NOTED THAT THE SHOCKS APPEARED TO BE DUE TO NOISE AND OVERSENSING. FURTHER EVALUATION WAS DONE AND A DIFFERENT SENSING VECTOR WAS PROGRAMMED. IT WAS THOUGHT THAT THE NOISE MAY HAVE BEEN RELATED TO INCISIONAL ISSUES AS BOTH OF THE ELECTRODE INCISIONS WERE OPEN THE ELECTRODE TIP HAD PROTRUDED THROUGH THE SKIN THE PREVIOUS WEEK. INCISIONAL INFECTION WAS ALSO NOTED AND BEING TREATED WITH ANTIBIOTICS. NO FURTHER INFORMATION RELATED TO THE TREATMENT PLAN WAS AVAILABLE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
306923	S-ICD SYSTEM	IMPLANTABLE LEAD	NVY	CAMERON HEALTH	3010

Patients

Seq	Age	Sex	Outcome	Treatment
1	31 YR		Life Threatening\| R	1010