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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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BOSTON SCIENTIFIC CORPORATION INVIVE PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number V173
Device Problems Pacing Problem (1439); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems Bradycardia (1751); Asystole (4442)
Event Date 02/21/2021
Event Type  Injury  
Manufacturer Narrative
The device has been returned for analysis. This report will be updated upon completion of analysis.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker declared safety mode. The following day the patient experienced ten seconds of asystole and was hospitalized. The device was explanted and replaced with a new device. No additional adverse patient effects were reported.
 
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Brand NameINVIVE
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (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 Key11661658
MDR Text Key245369250
Report Number2124215-2021-04792
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/18/2014
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number100325
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2016-2021

Patient Treatment Data
Date Received: 04/13/2021 Patient Sequence Number: 1
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