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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 High impedance (1291); Failure to Read Input Signal (1581)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/04/2020
Event Type  malfunction  
Manufacturer Narrative
Device technical analysis: 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. Engineering analysis and testing of returned products identified that any repeated, small movements of the lead terminal ring can create wearing of the lead terminal ring and generate microscopic particles, which may accumulate and oxidize over time. This can impact the connection between the spring contact and the lead ring, resulting in intermittent changes in impedance measurements. Investigation conclusion: intermittent pace impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection are likely the result of an intermittent high impedance condition associated with the device's 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) issued alerts in the remote monitoring system indicating the right atrial (ra) lead recorded a high, out-of-range pacing impendence measurement and the right ventricular (rv) lead exhibited an out-of-range intrinsic amplitude measurement. The local field representative planned to request more information from the facility about this patient and device. No adverse patient effects were reported. Available information indicates the device remains implanted and in service. Despite efforts, the field representative was not able to obtain additional details about this device and associated leads.
 
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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 Key10616134
MDR Text Key209588439
Report Number2124215-2020-19424
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/07/2017
Device Model NumberU225
Device Catalogue NumberU225
Device Lot Number700576
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 Received07/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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