FDA Adverse Event Injury Summary report: N

MEDTRONIC 6944/65

MDR report key: 3101344 · Received May 3, 2013

Report

Report Number
MW5030088
Event Type
Injury
Date Received
May 3, 2013
Date of Event
April 2, 2013
Report Date
May 3, 2013
Manufacturer
MEDTRONIC
Product Code
LWS
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
VA, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

EPISODES OF NSVT WERE REVIEWED AND CLEAR NOISE IS SEEN CORRESPONDING TO SHORT V-V INTERVALS. SHORT V-V INTERVALS WERE REPORTED UP TO 1365. LEAD WAS DISABLED AND PATIENT WORE LIFE VEST UNTIL NEW LEAD IMPLANTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
194552 MEDTRONIC 6944/65 SPRINT QUATRO LWS MEDTRONIC 6499/65 MFR

Patients

Seq Age Sex Outcome Treatment
1 70 YR Required Intervention