• 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 CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)

  • 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 CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) Back to Search Results
Model Number V173
Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems Fall (1848); Discomfort (2330); Syncope/Fainting (4411)
Event Date 05/01/2021
Event Type  Injury  
Manufacturer Narrative
The product has been received for analysis. This report would be updated should further information be provided from the analysis.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker recorded a red alert as it switched into safety mode, a device status that permanently limits available therapy to specific settings. Right atrial noise and oversensing was noticed on the electrogram (egm) due to the device programming changing to unipolar configuration. Patient is dependent and symptomatic, he was experiencing falling, fainting, blacking out, dizziness, "chills" on his arms and head; and palpitations. Technical services recommended replacement as soon as possible. The patient will be brought to the emergency room. Subsequently, this device was explanted, replaced and returned for analysis. No additional adverse patient effects were reported. Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior. This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINVIVE
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 Key12114317
MDR Text Key260293215
Report Number2124215-2021-16909
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 Other Health Care Professional
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 Received07/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/21/2014
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number101802
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 Received09/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2012
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: 07/04/2021 Patient Sequence Number: 1
-
-