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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 Premature Discharge of Battery (1057)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/01/2017
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical product: 2088tc x2 leads implanted: (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the device longevity was shorter each time the device was interrogated.It was noted the patient was in persistent atrial flutter.The device remains in use.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary : the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
VIVA XT CRT-P
Type of Device
PULSE 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 Key7094480
MDR Text Key94146559
Report Number9614453-2017-04572
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 health professional
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 02/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/28/2018
Device Model NumberC6TR01
Device Catalogue NumberC6TR01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/24/2017
Initial Date FDA Received12/07/2017
Supplement Dates Manufacturer Received12/20/2017
Supplement Dates FDA Received02/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/03/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
4196 LEAD
Patient Age70 YR
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