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 VIGILANT X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
  • 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 VIGILANT X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G247
Device Problems High impedance (1291); Pacing Problem (1439); Noise, Audible (3273)
Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/24/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited tones.When data was analyzed by boston scientific technical services (ts) it showed one value of high out of range pacing impedance measurement in the left ventricular (lv) lead channel.It was also noted that this lv lead impedance trend is getting closer to out of range values.Ts advice reprogramming options as the device is not pacing due to long av delays and intrinsic conduction; nevertheless, appropriate pacing capture was confirmed.At this time, this crt-d and lv lead remains in service.No adverse patient effects were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited tones.When data was analyzed by boston scientific technical services (ts) it showed one value of high out of range pacing impedance measurement in the left ventricular (lv) lead channel.It was also noted that this lv lead impedance trend is getting closer to out of range values.Ts advice reprogramming options as the device is not pacing due to long av delays and intrinsic conduction; nevertheless, appropriate pacing capture was confirmed.At this time, this crt-d and lv lead remains in service.No adverse patient effects were reported.
 
Manufacturer Narrative
Further engineering investigation was conducted of the device's diagnostic data that was downloaded and submitted to boston scientific technical services for review.It was determined that high out of range pacing impedance measurement] were not associated with the device's spring contact and lead terminal ring as previously reported.As all available evidence indicates the cause of the event was due to the rv lead and not the device, this event is no longer deemed to be a reportable incident.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited tones.When data was analyzed by boston scientific technical services (ts) it showed one value of high out of range pacing impedance measurement in the left ventricular (lv) lead channel.It was also noted that this lv lead impedance trend is getting closer to out of range values.Ts advice reprogramming options as the device is not pacing due to long av delays and intrinsic conduction; nevertheless, appropriate pacing capture was confirmed.At this time, this crt-d and lv lead remains in service.No adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VIGILANT X4 CRT-D
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key11181990
MDR Text Key227511411
Report Number2124215-2020-27081
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
PMA/PMN Number
P010012/S436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 10/05/2021
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 Date04/27/2022
Device Model NumberG247
Device Catalogue NumberG247
Device Lot Number237461
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/17/2020
Initial Date FDA Received01/15/2021
Supplement Dates Manufacturer Received01/28/2021
09/02/2021
Supplement Dates FDA Received04/26/2021
10/05/2021
Patient Sequence Number1
-
-