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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTUA IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

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BOSTON SCIENTIFIC CORPORATION INTUA IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER Back to Search Results
Model Number V273
Device Problems Over-Sensing (1438); Pacing Problem (1439)
Patient Problem Bradycardia (1751)
Event Date 01/13/2022
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited oversensing and pacing inhibition on the right ventricular lead. The patient is dependent on rv pacing and experienced asystole less than two seconds. As a result, the crt-p was reprogrammed and the rv sensing was adjusted. The plan is to continue monitoring the patient. No adverse patient effects were reported. At this time, the products remain in service.
 
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Brand NameINTUA
Type of DeviceIMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key13684599
MDR Text Key286749711
Report Number2124215-2022-04655
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526536670
UDI-Public00802526536670
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/11/2016
Device Model NumberV273
Device Catalogue NumberV273
Device Lot Number100744
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2014
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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