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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); Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)
Patient Problems Syncope/Fainting (4411); Asystole (4442)
Event Date 02/02/2021
Event Type  Injury  
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 malfunction or inadequate lead-to-device connection; please refer to the b5 describe event or problem 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.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system triggered a lead safety switch (lss) due to a high out of range right ventricular (rv) pacing impedance measurement of greater than 3000 ohms. There was some stored events due to oversensing of myopotential noise causing syncope. Boston scientific technical services reviewed the available data and recommended lead integrity testing. The rv lead was suspected to be fracture however a chest x-ray was performed and did not confirm any anomaly. The device was reprogrammed to unipolar temporary. Additionally, the patient was hospitalized due to the syncope and asystole. The duration of asystole is not known. The patient is currently being monitored. The plan is to replace the competitor rv lead with another competitor lead. This patient is pacemaker dependent. Subsequently, this crt-p and competitor rv lead were both explanted and replaced. There were no additional adverse patient effects reported. The device will not return for analysis.
 
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Brand NameVISIONIST 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 Key12708575
MDR Text Key278756040
Report Number2124215-2021-32740
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Modification/Adjustment
Type of Report Initial
Report Date 10/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/21/2022
Device Model NumberU225
Device Catalogue NumberU225
Device Lot Number715337
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/27/2021 Patient Sequence Number: 1
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