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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

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MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number DTBA1D1
Device Problems Electromagnetic Interference; Over-Sensing; Pacing Problem; Inappropriate Shock
Event Date 01/12/2017
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. Analysis of the device memory indicated oversensing due to emi (electromagnetic interference)/noise. Analysis of the device memory indicated the unexpected delivery of a ventricular tachyarrhythmia therapy. Concomitant product(s): blvbis10 lead, (b)(6) 2010. 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 received an inappropriate shock resulting in syncope. This was due to electromagnetic interference causing noise and oversensing and inhibition of right ventricular pacing. The patient was using a massager device at the time of the oversensing episodes. The device remains in use. No further patient complications have been reported as a result of this event.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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Brand NameVIVA XT
Type of DeviceDEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view , MN 55112
7635052036
MDR Report Key6467197
Report Number3004209178-2017-07323
Device Sequence Number1
Product CodeNIK
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/12/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/14/2018
Device MODEL NumberDTBA1D1
Device Catalogue NumberDTBA1D1
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 Received01/12/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/14/2016
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: 04/06/2017 Patient Sequence Number: 1
Treatment
0157 LEAD, 4518 LEAD, 4470 LEAD
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