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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)
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BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) Back to Search Results
Model Number U228
Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)
Patient Problem Presyncope (4410)
Event Date 11/01/2023
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system triggered a lead safety switch (lss) due to high out of range right ventricular (rv) impedance measurements greater than 2000 ohms, causing the device to switch from bipolar to unipolar configuration, which resulted in oversensing, pacing inhibition and presyncope for the patient.Boston scientific technical services (ts) reviewed data from the device and found noisy signals likely due to unipolar configuration, and also indicated that for the past 12 months, the rv pacing impedance trend includes high impedance peaks.Upon further troubleshooting and device interrogation, no noise or abnormalities were observed when in bipolar sensing.Of note, the implanted rv lead is a non-boston scientific product, and ts has two hypotheses for the reported observations; the first one being lead damage and the second one is a fretting problem between the lead and the device header.Further troubleshooting steps were provided in order to evaluate system integrity and if abnormalities are found, ts recommended lead replacement.At this time, no further information is available.Evidence suggests that this patient was hospitalized as they are pacing dependent.The device remains in service and no additional adverse patient effects have been reported.
 
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 description 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 high out of range right ventricular (rv) impedance measurements greater than 2000 ohms, causing the device to switch from bipolar to unipolar configuration, which resulted in oversensing, pacing inhibition and presyncope for the patient.Boston scientific technical services (ts) reviewed data from the device and found noisy signals likely due to unipolar configuration, and also indicated that for the past 12 months, the rv pacing impedance trend includes high impedance peaks.Upon further troubleshooting and device interrogation, no noise or abnormalities were observed when in bipolar sensing.Of note, the implanted rv lead is a non-boston scientific product, and ts has two hypotheses for the reported observations; the first one being lead damage and the second one is a fretting problem between the lead and the device header.Further troubleshooting steps were provided in order to evaluate system integrity and if abnormalities are found, ts recommended lead replacement.At this time, no further information is available.Evidence suggests that this patient was hospitalized as they are pacing dependent.The device remains in service and no additional adverse patient effects have been reported.
 
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Brand Name
VISIONIST X4 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 Key18949590
MDR Text Key338243427
Report Number2124215-2024-17176
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/13/2018
Device Model NumberU228
Device Catalogue NumberU228
Device Lot Number708540
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/01/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/10/2016
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;
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