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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 Problem Hematoma (1884)
Event Date 09/14/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that about one week after the device implant procedure, the patient experienced a hematoma. A pocket revision was done and an absorbable envelope was added. The device remains in use. No further patient complications have been reported as a result of this event.
 
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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 Key7092087
MDR Text Key94074571
Report Number9614453-2017-04243
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00643169351905
UDI-Public00643169351905
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
Report Date 12/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/28/2018
Device Model NumberC6TR01
Device Catalogue NumberC6TR01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/08/2017
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: 12/07/2017 Patient Sequence Number: 1
Treatment
4076-58 LEAD, 4076-52 LEAD, 4296-78 LEAD
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