FDA Adverse Event Injury Summary report: N

TRANSVENE RV

MDR report key: 3992634 · Received August 8, 2014

Report

Report Number: 2182208-2014-02377
Event Type: Injury
Date Received: August 8, 2014
Report Date: June 11, 2014
Manufacturer: MEDTRONIC, INC.
Product Code: LWS
PMA / PMN Number: P920015
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 419488 LEAD IMPLANTED: (B)(6) 2014; 507685 LEAD IMPLANTED: (B)(6) 2014. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD LOW PACING IMPEDANCE. IT WAS ALSO NOTED THAT THE PATIENT ALERT HAD BEEN TRIGGERED AND THAT THE PATIENT WAS VERY UPSET THAT THEY HAD DRIVEN TO ONE LOCATION FOR A DEVICE CHECK AND WAS REDIRECTED TO DRIVE ACROSS TOWN TO ANOTHER LOCATION FOR THE DEVICE CHECK. THE PATIENT STATED AS THEY WERE GOING INTO V-TACH, THEY FELT LIGHTHEADED, HOT, AND THOUGHT IT WAS POSSIBLE BLOOD PRESSURE OR HEART RELATED. FOLLOW UP WITH COMPANY REPRESENTATIVE REPORTED THAT THE EPISODE THE PATIENT WAS TALKING ABOUT WAS WHERE THE PATIENT WAS NOT FEELING WELL, RETURNED TO THE CLINIC, AND IT WAS FOUND THAT THE PATIENT HAD A VT EPISODE THAT WAS TREATED PROPERLY BY THE DEVICE BY TREATING THE RHYTHM WITHOUT USE OF HIGH POWERED SHOCK. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
470155	TRANSVENE RV	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER	LWS	MEDTRONIC, INC.	6936-65

Patients

Seq	Age	Sex	Outcome	Treatment
1	00075 YR		Required Intervention	DTBA1D1 ICD