BI,FINNED,VS-1 ENDO LEAD

Report

• Report Number: 3010215456-2015-33043
• Event Type: Injury
• Date Received: December 22, 2015
• Date of Event: November 12, 2015
• Report Date: November 12, 2015
• Manufacturer: ST. JUDE MEDICAL, INC. (CRM-KISTA)
• Product Code: NVN
• Adverse Event: Yes
• Product Problem: Yes
• Report Source: Manufacturer report
• Reporter Location: GM
• Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED TO HAVE SURGERY THE FOLLOWING, SO THE PHYSICIAN CHECKED THE PATIENT THE DAY BEFORE. THE PHYSICIAN ELECTED TO CHANGE THE DEVICE SETTINGS AND 16 HOURS AFTER THE PROGRAMMING CHANGES WERE PERFORMED EXIT BLOCK OCCURRED AND THE PATIENT COLLAPSED. THE PHYSICIAN DIAGNOSED THE PATIENT WITH SAB AND TREATED THE PATIENT CONSERVATIVELY WITHOUT SURGICAL INTERVENTION. THE PATIENT WAS IN STABLE CONDITION AND THE LEAD REMAINED IMPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
843235	BI,FINNED,VS-1 ENDO LEAD	PERMANENT PACEMAKER ELECTRODE	NVN	ST. JUDE MEDICAL, INC. (CRM-KISTA)	1010T

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR		Required Intervention

Terms

Patient problem · 2

• Collapse
• Exit Block

Product problems · 1

• Failure to Capture

Source type · 2

• COMPANY REPRESENTATIVE
• FOREIG