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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U225
Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)
Patient Problem Asystole (4442)
Event Date 02/23/2023
Event Type  malfunction  
Event Description
It was reported that the cardiac resynchronization therapy pacemaker (crt-p) system recorded an automatic safety switch from bipolar to unipolar due to a left ventricular (lv) pace impedance measurement greater than 3000 ohms.Additionally, there was oversensing noise on the right ventricular (rv) channel that caused pacing inhibition greater than 2 seconds.The patient was seen, and noise was not able to be reproduced with the device and patient arm maneuvers.Data was reviewed and boston scientific technical services provided troubleshooting options.No additional adverse patient effects were reported.The device, lv lead and rv lead remain in-service.
 
Event Description
It was reported that the cardiac resynchronization therapy pacemaker (crt-p) system recorded an automatic safety switch from bipolar to unipolar due to a left ventricular (lv) pace impedance measurement greater than 3000 ohms.Additionally, there was oversensing noise on the right ventricular (rv) channel that caused pacing inhibition greater than 2 seconds.The patient was seen, and noise was not able to be reproduced with the device and patient arm maneuvers.Data was reviewed and boston scientific technical services provided troubleshooting options.No additional adverse patient effects were reported.The device, lv lead and rv lead remain in-service.
 
Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a product performance issue or inadequate lead-to-device connection; please refer to the section b5 for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.Additionally, the oversensing, noise and brady pacing not delivered when required are known inherent risk with use of this product.
 
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Brand Name
VISIONIST 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 Key18564803
MDR Text Key333492576
Report Number2124215-2024-03365
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Remedial Action Notification
Type of Report Initial,Followup
Report Date 02/07/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/29/2024
Device Model NumberU225
Device Catalogue NumberU225
Device Lot Number722356
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/06/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/12/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age93 YR
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