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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IPG MFG SWITZERLAND VIVA XT CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

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IPG MFG SWITZERLAND VIVA XT CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number C6TR01
Device Problems Incorrect Measurement (1383); Unable to Obtain Readings (1516)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/19/2015
Event Type  malfunction  
Manufacturer Narrative
The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. Concomitant product: 1648t st jude lead, implanted: (b)(6) 2007. (b)(4).
 
Event Description
It was reported that, at implant, the implantable pulse generator (ipg) device measured the lead impedances prior to turning off implant detect. Measurements were as expected with the atrial port plugged. Right after turning off implant detect and re-measuring, the impedance measurements displayed as ¿not taken. ¿ within seconds a second measurement was taken with implant detect turned off and ¿not taken¿ resulted again. Measurements were taken a third time within seconds with implant detect still turned off and this time measurements were as expected. The device remains in use. No 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)
IPG MFG SWITZERLAND
route du molliau 31
tolochenaz 1131
CH 1131
Manufacturer (Section G)
MEDTRONIC CARDIAC RHYTHM HEART FAILURE
8200 coral sea st ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key5425278
MDR Text Key38358877
Report Number9614453-2016-01327
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
Report Date 11/19/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2017
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 Received11/19/2015
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/02/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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