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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)
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BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) Back to Search Results
Model Number U225
Device Problems Premature Discharge of Battery (1057); Pocket Stimulation (1463)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/19/2023
Event Type  Injury  
Event Description
It was reported that the battery of this implantable pacemaker was suspected to be depleting prematurely.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.As a result, device replacement within 90 days or more frequent monitoring was recommended.No adverse patient effects were reported.
 
Event Description
It was reported that the battery of this implantable pacemaker was suspected to be depleting prematurely.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.As a result, device replacement within 90 days or more frequent monitoring was recommended.Additional information was received.Diaphragmatic stimulation was noted.This pacemaker was subsequently explanted and is expected to be returned to boston scientific for analysis.No additional adverse patient effects were reported.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.A high current drain was detected, but the battery still supported full device function.Detailed analysis confirmed the identified high current drain was a result of compromised capacitors.This resulted in the observed premature battery depletion.It was determined that the capacitors were compromised due to the presence of excess hydrogen in the device case.Boston scientific issued a field safety notice regarding a subset of devices in the accolade pacemaker family that have a potential of exhibiting this behavior.This particular device is included in the hydrogen induced premature depletion advisory population.
 
Event Description
It was reported that the battery of this cardiac resynchronization therapy pacemaker (crt-p) was suspected to be depleting prematurely.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.As a result, device replacement within 90 days or more frequent monitoring was recommended.Additional information was received.Diaphragmatic stimulation was noted.This crt-p was subsequently explanted and returned to boston scientific for analysis.No additional adverse patient effects were reported.
 
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Brand Name
VISIONIST CRT-P
Type of Device
CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (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 Key17785503
MDR Text Key323903017
Report Number2124215-2023-51495
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Physician
Remedial Action Notification
Type of Report Initial,Followup,Followup
Report Date 02/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/12/2018
Device Model NumberU225
Device Catalogue NumberU225
Device Lot Number702809
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/30/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2016
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 Age7 YR
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