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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; IMPLANTABLE PACEMAKER
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BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; IMPLANTABLE PACEMAKER Back to Search Results
Model Number U128
Device Problems Pocket Stimulation (1463); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 10/05/2022
Event Type  Injury  
Event Description
It was reported that this implantable pacemaker was explanted due to entering in safety mode.Furthermore, the patient experienced pocket stimulation.Another device was implanted instead.No further adverse patient effects were reported.
 
Event Description
It was reported that this implantable pacemaker was explanted due to entering in safety mode.Furthermore, the patient experienced pocket stimulation.Another device was implanted instead.This device was returned to boston scientific for evaluation.No further adverse patient effects were reported.
 
Manufacturer Narrative
The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was interrogated with a programmer and found to be operating in safety mode.This device was not able to maintain telemetry connection long enough to obtain a memory download for review.The device case was removed to facilitate inspection and testing of the internal components.The battery was disconnected from the hybrid assembly and detailed testing determined that this device experienced high impedance in the battery.However, a definitive cause of this high impedance behavior has not been determined.
 
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Brand Name
VALITUDE X4 CRT-P
Type of Device
IMPLANTABLE PACEMAKER
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 Key15584669
MDR Text Key301548045
Report Number2124215-2022-40965
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 Physician
Type of Report Initial,Followup
Report Date 05/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/07/2019
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number723101
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/24/2017
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 Age87 YR
Patient SexFemale
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