• 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 VALITUDE CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (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 VALITUDE CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U125
Device Problems Signal Artifact/Noise (1036); High impedance (1291); High Capture Threshold (3266)
Patient Problems Syncope (1610); Syncope/Fainting (4411)
Event Date 01/02/2020
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system exhibited intermittent high out of range pace impedance measurements as well as intermittent high thresholds on the right ventricular (rv) channel.The high impedance spikes were first observed approximately one (1) month ago.There was also an associated lead safety switch (lss) noted.In addition, some noise was observed during isometric testing.The rv lead is not a boston scientific product.The patient reported to have had an episode of syncope approximately two (2) weeks ago.The device was subsequently programmed to unipolar pacing and the patient was admitted to the hospital.The boston scientific representative indicated they will discuss a possible device and rv lead replacement with the physician.The products remain in-service at this time.No additional 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 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.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system exhibited intermittent high out of range pace impedance measurements as well as intermittent high thresholds on the right ventricular (rv) channel.The high impedance spikes were first observed approximately one (1) month prior.There was also an associated lead safety switch (lss) noted.In addition, some noise was observed during isometric testing.The right atrial (ra), rv and left ventricular (lv) leads are not boston scientific products.The patient reported having an episode of syncope approximately two (2) weeks prior.The device was subsequently programmed to unipolar pacing and the patient was admitted to the hospital.The boston scientific representative indicated they will discuss a possible device and rv lead replacement with the physician.The entire system was subsequently explanted and replaced.No additional 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 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.This correction supplemental report was submitted based on subsequent information that when the crt-p system, including this crt-p device, was replaced, it was not explanted but was deactivated and remains implanted.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system exhibited intermittent high out of range pace impedance measurements as well as intermittent high thresholds on the right ventricular (rv) channel.The high impedance spikes were first observed approximately one (1) month prior.There was also an associated lead safety switch (lss) noted.In addition, some noise was observed during isometric testing.The right atrial (ra), rv and left ventricular (lv) leads are not boston scientific products.The patient reported having an episode of syncope approximately two (2) weeks prior.The device was subsequently programmed to unipolar pacing and the patient was admitted to the hospital.The boston scientific representative indicated they will discuss a possible device and rv lead replacement with the physician.The entire system was subsequently explanted and replaced.No additional adverse patient effects were reported.Subsequent information was received that when this crt-p system was replaced, it was not explanted but was deactivated and remains implanted.No additional adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VALITUDE CRT-P
Type of Device
PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (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 Key9924578
MDR Text Key186721603
Report Number2124215-2020-03708
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526559389
UDI-Public00802526559389
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 05/08/2024
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 Date08/24/2019
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number706823
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/02/2020
Initial Date FDA Received04/03/2020
Supplement Dates Manufacturer Received02/06/2020
04/26/2024
Supplement Dates FDA Received04/25/2020
05/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/11/2017
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age79 YR
Patient SexFemale
-
-