• 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 Problems Over-Sensing (1438); Pacing Problem (1439); Off-Label Use (1494)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2022
Event Type  malfunction  
Event Description
It was reported that this patient was downgraded from an implantable cardioverter defibrillator to a biventricular cardiac resynchronization therapy pacemaker during which the right ventricular (rv) port plug was capped and the device was being used as a left ventricular only device. Post procedure, the device was performing electrical measurements every 2 seconds looking for the rv lead, due to the auto lead detect feature. The electrical measurements were being oversensed, causing pacing inhibition. It was noted that the patient was not pacemaker dependent at the time. Boston scientific technical services discussed options with the field representative. The device remains in service. No adverse patient effects were reported.
 
Manufacturer Narrative
If additional information is received, a supplemental report will be filed at that time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVALITUDE X4 CRT-P
Type of DevicePULSE 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 Key13684613
MDR Text Key286747330
Report Number2124215-2022-04388
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
Type of Report Initial
Report Date 03/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number767091
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-