• 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 TELIGEN; IMPLANTABLE PACEMAKER

  • 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 TELIGEN; IMPLANTABLE PACEMAKER Back to Search Results
Model Number E110
Device Problems Device Alarm System (1012); Premature Discharge of Battery (1057); Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/13/2022
Event Type  Injury  
Event Description
It was reported that the battery of this implantable cardioverter defibrillator (icd) was suspected to be depleting prematurely as it decreased to 5 months of battery life remaining faster than expected.Additionally, the device presented some beeping tones suspected to be caused by a fault code 1003.This is indicative of battery voltage too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis is still pending since files are required in pgd format and there was only pdf available, with this type of format it is not possible to conduct data analysis.The device remains in service and the patient has been scheduled for device replacement.No adverse patient effects were reported.
 
Event Description
It was reported that the battery of this implantable cardioverter defibrillator (icd) was suspected to be depleting prematurely as it decreased to 5 months of battery life remaining faster than expected.Additionally, the device presented some beeping tones suspected to be caused by a fault code 1003.This is indicative of battery voltage too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis is still pending since files are required in pgd format and there was only pdf available, with this type of format it is not possible to conduct data analysis.The device has been explanted and replaced.No additional adverse patient effects were reported.
 
Manufacturer Narrative
The returned cognis teligen was analyzed.The battery voltage was lower than expected, but still supported full device function.Using historical daily battery voltage measurement data, engineers determined that this device was demonstrating behavior consistent with a high current condition associated with a compromised low voltage capacitor connected to the device battery.Low voltage capacitors are used in the high voltage charging operation in order to facilitate fast charge times.The behavior of these capacitors resulted in a high current drain, which was depleting the device battery faster than normal.Boston scientific has issued an advisory communication regarding an older subset of cognis/teligen devices that is more susceptible to this anomaly.Specifically, the performance of a low voltage capacitor may be compromised over time, causing an increased current drain that can lead to premature battery depletion.This particular device was included in the advisory population.
 
Event Description
It was reported that the battery of this implantable cardioverter defibrillator (icd) was suspected to be depleting prematurely as it decreased to 5 months of battery life remaining faster than expected.Additionally, the device presented some beeping tones suspected to be caused by a fault code 1003.This is indicative of battery voltage too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis is still pending since files are required in pgd format and there was only pdf available, with this type of format it is not possible to conduct data analysis.The device has been explanted and replaced.No additional adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TELIGEN
Type of Device
IMPLANTABLE PACEMAKER
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 Key14107708
MDR Text Key289262195
Report Number2124215-2022-10288
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P960040/S155
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Remedial Action Notification
Type of Report Initial,Followup,Followup
Report Date 08/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/01/2010
Device Model NumberE110
Device Catalogue NumberE110
Device Lot Number128048
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/10/2022
Initial Date FDA Received04/13/2022
Supplement Dates Manufacturer Received04/04/2022
08/18/2022
Supplement Dates FDA Received05/21/2022
08/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/12/2009
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 Outcome(s) Required Intervention; Hospitalization;
Patient Age71 YR
Patient SexMale
-
-