FDA Adverse Event Injury Summary report: N

INGENIO

MDR report key: 3211168 · Received July 8, 2013

Report

Report Number: 2124215-2013-09716
Event Type: Injury
Date Received: July 8, 2013
Date of Event: April 24, 2013
Report Date: April 24, 2013
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: NVZ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE IS STILL IN USE AT THIS TIME AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS SEPTIC AND HAD A SYSTEMIC INFECTION. IT IS UNKNOWN IF THE INFECTION SPREAD FROM THE POCKET TO THE PATIENT OR FROM THE PATIENT TO THE POCKET. THE PHYSICIAN DOES NOT SUSPECT THE INFECTION IS RELATED TO THE DEVICE IMPLANT. THE SYSTEM WAS EXPLANTED AND THIS DEVICE IS BEING UTILIZED OUTSIDE THIS PATIENT'S BODY TO PROVIDE PACING THERAPY. DURING THE EXPLANT PROCEDURE, THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA (VT) AND HAD TO BE EXTERNALLY RESCUED. THE PATIENT WAS PUT ON A VENTILATOR AND ANTIBIOTICS AND THE TEMPORARY SYSTEM WILL MOST LIKELY BE REPLACED WITH A RIGHT SIDED TRANSVENOUS SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
310757	INGENIO	IMPLANTABLE PULSE GENERATOR	NVZ	GUIDANT CRM CLONMEL IRELAND	K173

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Hospitalization\| L	4137\| 4470\| K173