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 VALITUDE X4 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 X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U128
Device Problem Material Integrity Problem (2978)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 11/10/2023
Event Type  malfunction  
Event Description
It was reported that during the implant of this cardiac resynchronization therapy pacemaker (crt-p), once placed into the pocket, bipolar right ventricular (rv) pacing resulted in chest muscle stimulation that was visually observed through from this device header.This crt-p had been taken out of storage mode today.Unipolar testing was fine with no stimulation.Rv lead and impedance testing showed normal measurements.The right atrial (ra) lead was placed into the rv port for testing purposes in which the same issue was observed.Rv only pacing was attempted and was not biventricular (bv) pacing at the time.True bipolar on lv lead was observed.Bipolar pacing was attempted on the pacing system analyzer (psa) with no issues.The psa ring unipolar did not reproduce it.Muscle stimulation was also recreated with the rv lead in the ra port, noting that both ports of this crt-p header resulted in the stimulation.Technical services (ts) noted this was likely not a lead issue as the leads were tested fine with the psa.Ultimately, the physician decided to implant a different device.This new device remains in service.No adverse patient effects were reported.
 
Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
 
Manufacturer Narrative
This device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination identified no anomalies.Functional testing was undertaken and the device did not perform as expected.Additionally, the device was found to be operating in safety mode.The device case was removed to facilitate inspection and testing of the internal components.High powered visual inspection found that the battery insulation liner did not completely insulate the battery, resulting in the battery case making contact with the device case.This resulted in the reported clinical observations and the reversion to safety mode operation.Correction to b1 to change to product problem and removed b2 selections.
 
Event Description
It was reported that during the implant of this cardiac resynchronization therapy pacemaker (crt-p), once placed into the pocket, bipolar right ventricular (rv) pacing resulted in chest muscle stimulation that was visually observed through from this device header.This crt-p had been taken out of storage mode today.Unipolar testing was fine with no stimulation.Rv lead and impedance testing showed normal measurements.The right atrial (ra) lead was placed into the rv port for testing purposes in which the same issue was observed.Rv only pacing was attempted and was not biventricular (bv) pacing at the time.True bipolar on lv lead was observed.Bipolar pacing was attempted on the pacing system analyzer (psa) with no issues.The psa ring unipolar did not reproduce it.Muscle stimulation was also recreated with the rv lead in the ra port, noting that both ports of this crt-p header resulted in the stimulation.Technical services (ts) noted this was likely not a lead issue as the leads were tested fine with the psa.Ultimately, the physician decided to implant a different device.This new device remains in service.No adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VALITUDE X4 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 Key18239389
MDR Text Key329391654
Report Number2124215-2023-67944
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526559402
UDI-Public00802526559402
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 Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 11/30/2023
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 Model NumberU128
Device Catalogue NumberU128
Device Lot Number788994
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/10/2023
Initial Date FDA Received11/30/2023
Date Device Manufactured08/02/2023
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) Hospitalization; Required Intervention;
Patient Age82 YR
Patient SexFemale
-
-