• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE IMPLANTABLE DEVICE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION INVIVE IMPLANTABLE DEVICE Back to Search Results
Model Number V173
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Device Displays Incorrect Message (2591)
Patient Problems Discomfort (2330); No Code Available (3191)
Event Date 10/31/2019
Event Type  Injury  
Manufacturer Narrative
Boston scientific received information that the patient was presented to the electrophysiology laboratory. The device was explanted and replaced with a non-boston scientific device. There were no reported complications as a result of the explant procedure. The explanted device was received at boston scientific return product department on (b)(6) 2019 and is currently undergoing laboratory testing to determine root cause.
 
Event Description
It was reported that this health care professional (hcp) contacted boston scientific technical service on (b)(6) 2019. The hcp commented that a red alert had been declared but the hcp did not receive an email. Boston scientific latitude tier 2 confirmed that an email notification was sent on (b)(6) 2019 at 6:34:41 am due to a red alert. According to the hcp, the patient arrived at the clinic and was not feeling well. It was determined that the device was in safety core. The technical service consultant explained that the device should be explanted and replaced immediately as the functionality of the device could not be guaranteed. The hcp was informed that this may not be a battery issue, but the replacement urgency is due because the device is sensing in unipolar configuration.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9646693
MDR Text Key176963210
Report Number2124215-2019-28853
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
Type of Report Initial,Followup
Report Date 02/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/12/2014
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number102314
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2012
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: 01/30/2020 Patient Sequence Number: 1
-
-