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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL VIVA XT CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

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MEDTRONIC EUROPE SARL VIVA XT CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number C6TR01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Sepsis (2067); Septic Shock (2068)
Event Date 08/20/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 429688 lead, implanted: (b)(6) 2017. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the cardiac resynchronization therapy pacemaker (crt-p) system was removed due infection of systemic bacteremia, (b)(6) and sepsis. There was vegetation on the leads and the patient experienced septic shock. The patient is to receive a new system at a future date. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the device was returned and analyzed and no anomalies were found. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameVIVA XT CRT-P
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7876605
MDR Text Key120262585
Report Number9614453-2018-03193
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/14/2017
Device Model NumberC6TR01
Device Catalogue NumberC6TR01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/14/2018 Patient Sequence Number: 1
Treatment
5076-65 LEAD, 5076-58 LEAD
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