Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 COGNIS; IMPLANTABLE DEFIBRILLATOR
  • 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 COGNIS; IMPLANTABLE DEFIBRILLATOR Back to Search Results
Model Number N119
Device Problem High impedance (1291)
Patient Problem Unspecified Heart Problem (4454)
Event Date 09/14/2022
Event Type  malfunction  
Event Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited high out of range shock impedance measurements.Since the device also reached end of life (eol) it was decided to address this issue the day of the replacement procedure.Additionally the patient experienced palpitations.At this time no changes have been performed.This device remains in service.No further adverse patient effects were reported.
 
Manufacturer Narrative
This device passed all returned product testing; however, boston scientific has initiated an investigation into the behavior described in the event description, including consideration of potential design enhancements, as deemed appropriate.Additional information was corrected from the following fields: h6: impact codes.
 
Event Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited high out of range shock impedance measurements.Since the device also reached end of life (eol) it was decided to address this issue the day of the replacement procedure.Additionally, the patient experienced palpitations.At this time no changes have been performed.This device remains in service.No further adverse patient effects were reported.Additional information was received detailing that this device was explanted due to normal battery depletion.This device was returned to boston scientific for analysis.
 
Manufacturer Narrative
Additional information was corrected from the following fields: h6: impact codes.
 
Event Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited high out of range shock impedance measurements.Since the device also reached end of life (eol) it was decided to address this issue the day of the replacement procedure.Additionally the patient experienced palpitations.At this time no changes have been performed.This device remains in service.No further adverse patient effects were reported.
 
Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that there was no conclusive evidence that the observed out-of-range impedance measurements were due to a malfunction or an inadequate lead-to-device connection.However, intermittent, out-of-range shock lead impedance measurements with no conclusive evidence of a malfunction or an inadequate lead-to-device connection are likely the result of the low-energy test signal utilized for daily automatic or in-clinic commanded shock lead impedance testing.A software update was released in 2015 to further improve consistency of the impedance test results and provide the clinician with additional diagnostic tools, including programmable shock lead impedance alert limits.Additional information was corrected from the following fields: h6: impact codes.
 
Event Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited high out of range shock impedance measurements.Since the device also reached end of life (eol) it was decided to address this issue the day of the replacement procedure.Additionally, the patient experienced palpitations.At this time no changes have been performed.This device remains in service.No further adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COGNIS
Type of Device
IMPLANTABLE DEFIBRILLATOR
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 Key15514730
MDR Text Key301523152
Report Number2124215-2022-38847
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010012/S165
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 12/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/29/2012
Device Model NumberN119
Device Catalogue NumberN119
Device Lot Number504145
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/14/2022
Initial Date FDA Received09/30/2022
Supplement Dates Manufacturer Received09/14/2022
10/10/2022
12/07/2022
Supplement Dates FDA Received10/06/2022
10/13/2022
12/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age81 YR
Patient SexFemale
-
-