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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTUA CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)

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BOSTON SCIENTIFIC CORPORATION INTUA CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) Back to Search Results
Model Number V273
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 06/01/2021
Event Type  Injury  
Manufacturer Narrative
The product has been received for analysis. This report will be updated upon completion of analysis, should pertinent information be provided.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode during a routine check. The patient reported experiencing phrenic nerve stimulation. It was recommended that this device be replaced. The device was subsequently explanted and replaced. No additional adverse patient effects. This product was returned for analysis. This device is included in the high impedance in ingenio el pacemakers and crt-ps advisory population.
 
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Brand NameINTUA
Type of DeviceCARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)
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 Key12114030
MDR Text Key260240695
Report Number2124215-2021-16366
Device Sequence Number1
Product Code NKE
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 company representative
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup
Report Date 10/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/12/2016
Device Model NumberV273
Device Catalogue NumberV273
Device Lot Number101179
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/03/2021 Patient Sequence Number: 1
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