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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 Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Dizziness (2194)
Event Date 07/20/2021
Event Type  Injury  
Manufacturer Narrative
Information indicates this device is currently in the possession of the explanting hospital. This investigation will be updated should further information be provided.
 
Event Description
It was reported that this patient presented to the emergency room (er) with symptoms of dizziness. Upon interrogation, this cardiac resynchronization therapy pacemaker (crt-p) device was found to have reverted to safety mode with limited critical therapy still available. The patient was indicated to have mobitz type ii av block. Boston scientific technical services (ts) discussed with the er physician the devices settings when in safety mode and explained the potential for pacing inhibition to occur. The er physician was going to discuss with the electrophysiologist about performing a device replacement procedure as soon as possible. The device was subsequently explanted and replaced the next day. No additional 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 Key12620254
MDR Text Key276359696
Report Number2124215-2021-23754
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 health professional
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2015
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number103536
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2013
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: 10/12/2021 Patient Sequence Number: 1
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