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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)

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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 Pocket Stimulation (1463)
Patient Problems Muscle Stimulation (1412); Palpitations (2467)
Event Date 10/11/2019
Event Type  malfunction  
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) device caused the patient to experienced stimulation and pounding heart.Also, the device had no pacing.Boston scientific technical services (ts) discussed that this device was intended to be a bi-v pacing device with 100% pacing and the presenting shows all sinus rhythm.This device remains in service.No adverse patient effects were reported.
 
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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 Key9570460
MDR Text Key174366368
Report Number2124215-2019-27744
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/09/2020
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 Model NumberU128
Device Catalogue NumberU128
Device Lot Number744981
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/11/2019
Initial Date FDA Received01/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/14/2019
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age72 YR
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