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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 Problem Capturing Problem (2891)
Patient Problem Torsades-de-Pointes (2107)
Event Date 05/28/2016
Event Type  Injury  
Manufacturer Narrative
Product event summary: the device was not returned for analysis. However, performance data collected from the device was received and analyzed. No anomalies were found. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient presented with torsades de pointes, and required external shock one time with cardiopulmonary resuscitation for several minutes. It was also noted that the previous device check showed sinus rhythm, although no atrial lead was placed. The torsades was initiated during the capture management testing, however it was unknown if the testing caused the torsades. The capture management for the patient's right ventricular (rv) lead and left ventricular (lv) lead was reprogrammed off. The rv lead was later capped, the lv lead remains in use and the device was explanted and replaced. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the device was returned and analyzed. Analysis was performed and no anomalies were found. Analysis of the device memory was performed and no anomalies were found.
 
Manufacturer Narrative
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)
IPG MFG SWITZERLAND
route du molliau 31
tolochenaz 1131
CH 1131
Manufacturer (Section G)
IPG MFG SWITZERLAND
route du molliau 31
tolochenaz 1131
CH 1131
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key5860715
MDR Text Key51723543
Report Number9614453-2016-05156
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,Followup
Report Date 05/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2015
Device Model NumberC6TR01
Device Catalogue NumberC6TR01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2014
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: 08/09/2016 Patient Sequence Number: 1
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