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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 Incorrect, Inadequate or Imprecise Result or Readings (1535); Interrogation Problem (4017)
Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Event Date 01/06/2021
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 this cardiac resynchronization therapy pacemaker was found to be in safety mode. This was found during an attempt to interrogate the device during this device changeout procedure. The leads were found to be ok. The patient was pacemaker dependent at the time. The cause of the safety mode is unknown at this time. No 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 Key11232915
MDR Text Key228846842
Report Number2124215-2021-02067
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526536632
UDI-Public00802526536632
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 06/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/17/2014
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number100865
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2012
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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