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 INGEVITY+; IMPLANTABLE LEAD
  • 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 INGEVITY+; IMPLANTABLE LEAD Back to Search Results
Model Number 7842
Device Problems Difficult to Insert (1316); Mechanical Problem (1384); Over-Sensing (1438); Failure to Read Input Signal (1581)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/06/2021
Event Type  Injury  
Manufacturer Narrative
Information indicates this lead will be returned.This investigation will be updated should further information be provided.
 
Event Description
It was reported that this right ventricular (rv) lead sensitivity programming was increased based on an observed decrease in rv intracardiac amplitude.However, t-wave oversensing was subsequently observed.As a result, it was decided to attempt to surgically reposition the rv lead.During the surgical procedure, it was noted that the stylet was inserted into the rv lead lumen but it would only advance to approximately 10 centimeters from the distal end of the lead.In addition, the lead helix was unable to be retracted after 30 rotations.As a result, it was determined that the lead could not be repositioned due to the extended helix.The lead was eventually able to be extracted from the cardiac tissue by rotating the lead body.The lead was explanted and replaced with a new rv lead of the same model number and the surgical procedure was completed successfully.No additional adverse patient effects were reported.
 
Manufacturer Narrative
Information indicates this lead will be returned.This investigation will be updated should further information be provided.Correction to field h6: device codes.Added an additional device code associated with the low amplitude rv intracardiac signal that was reported.
 
Event Description
It was reported that this right ventricular (rv) lead sensitivity programming was increased based on an observed decrease in rv intracardiac amplitude.However, t-wave oversensing was subsequently observed.As a result, it was decided to attempt to surgically reposition the rv lead.During the surgical procedure, it was noted that the stylet was inserted into the rv lead lumen but it would only advance to approximately 10 centimeters from the distal end of the lead.In addition, the lead helix was unable to be retracted after 30 rotations.As a result, it was determined that the lead could not be repositioned due to the extended helix.The lead was eventually able to be extracted from the cardiac tissue by rotating the lead body.The lead was explanted and replaced with a new rv lead of the same model number and the surgical procedure was completed successfully.No additional adverse patient effects were reported.
 
Event Description
It was reported that this right ventricular (rv) lead sensitivity programming was increased based on an observed decrease in rv intracardiac amplitude.However, t-wave oversensing was subsequently observed.As a result, it was decided to attempt to surgically reposition the rv lead.During the surgical procedure, it was noted that the stylet was inserted into the rv lead lumen but it would only advance to approximately 10 centimeters from the distal end of the lead.In addition, the lead helix was unable to be retracted after 30 rotations.As a result, it was determined that the lead could not be repositioned due to the extended helix.The lead was eventually able to be extracted from the cardiac tissue by rotating the lead body.The lead was explanted and replaced with a new rv lead of the same model number and the surgical procedure was completed successfully.No additional adverse patient effects were reported.
 
Manufacturer Narrative
Information indicates this lead will be returned.This investigation will be updated should further information be provided.Correction to field h6: device codes.Added an additional device code associated with the low amplitude rv intracardiac signal that was reported.Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance and inner insulation integrity.Measurements were within normal limits, indicating lead conductors are intact and there are no electrical shorts between the conductors.The stylet used in the lead revision procedure was returned still within the lead body and could not be removed due to dried blood in the terminal pin opening and on the stylet.The helix was retracted, and there was dried blood and body fluid in the helix housing and tip region.This prevented direct testing of the helix mechanism as the terminal pin no longer rotates freely.The lead tip appears intact and undamaged.The clinical observations of the inability to fully insert the stylet into the lead lumen and the inability to retract the helix during the attempted lead revision were confirmed based on the field report as well as the observation of dried flood and body fluid in the lead lumen, in the helix housing and lead tip region.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INGEVITY+
Type of Device
IMPLANTABLE LEAD
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
road 698, lot no. 12
dorado PR 00646 -260
*   00646-2602
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key12644195
MDR Text Key276855108
Report Number2124215-2021-29275
Device Sequence Number1
Product Code NVN
UDI-Device Identifier00802526604522
UDI-Public00802526604522
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P150012/S083
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/13/2022
Device Model Number7842
Device Catalogue Number7842
Device Lot Number1016667
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2020
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexMale
-
-