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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE IMPLANTABLE DEVICE

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BOSTON SCIENTIFIC CORPORATION INVIVE IMPLANTABLE DEVICE Back to Search Results
Model Number V173
Device Problem Pacing Problem (1439)
Patient Problem Insufficient Information (4580)
Event Date 04/27/2021
Event Type  malfunction  
Manufacturer Narrative
The device has been returned for analysis. This report will be updated upon completion of analysis.
 
Event Description
It was reported that an interrogation was performed on this implanted cardiac resynchronization therapy pacemaker (crt-p) device on the morning that the device was scheduled to be replaced for normal battery depletion. The boston scientific representative indicated that during the interrogation, there were visible p-waves, but no pacing was observed and there was asystole for an estimated six beats. When the programmer wand was removed from the device, normal atrial and bi-ventricular device pacing resumed. Boston scientific technical services (ts) discussed that there is no clear reason why this might happen. Ts provided guidance to check the leads as they were implanted approximately ten years ago. The device was subsequently explanted and replaced as scheduled later that day, and the leads remain in-service. No patient symptoms or adverse patient effects were reported.
 
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Brand NameINVIVE
Type of DeviceIMPLANTABLE DEVICE
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 Key12112973
MDR Text Key260447705
Report Number2124215-2021-14452
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S079
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/19/2014
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number102581
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/04/2013
Is the Device Single Use? Yes
Type of Device Usage Initial
Removal/Correction NumberZ-2018-2021

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