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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); Connection Problem (2900)
Patient Problems Presyncope (4410); Asystole (4442)
Event Date 10/10/2023
Event Type  Injury  
Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed, and this report will be updated at that time.
 
Event Description
It was reported that this patient attended the clinic with symptoms of presyncope.Upon device interrogation, it was noted that this cardiac resynchronization therapy pacemaker (crt-p) system had triggered a lead safety switch (lss) due to a high out of range right ventricular (rv) pacing impedance measurements greater than 3000 ohms.Additionally, episodes with oversensing of noise on the ventricular channel were found, which included periods of greater than 14 seconds of asystole.As a result, the patient was admitted to the hospital and a new non-boston scientific rv lead was implanted with evidence of optimal electrical measurements on the pacing system analyzer, but when the physician connected this lead to the already implanted crt-p, no change in the pacing morphology could be observed on the electrocardiogram, and high out of range pacing impedance measurements and noise were present.Further troubleshooting was performed, an after manipulating the device, it was noted that the noise improved but it was being oversensed, and the pacing impedance was still high out of range, measuring 2400 ohms.Consequently, the physician made the decision to explant the crt-p device and a non-boston scientific product was implanted instead as a device header connection problem was suspected.The procedure was completed successfully, and no additional adverse patient effects were reported.The device is expected to be returned for analysis.
 
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.At this time, the product has not been returned.If the product is returned, analysis will be performed, and this report will be updated at that time.
 
Event Description
It was reported that this patient attended the clinic with symptoms of presyncope.Upon device interrogation, it was noted that this cardiac resynchronization therapy pacemaker (crt-p) system had triggered a lead safety switch (lss) due to a high out of range right ventricular (rv) pacing impedance measurements greater than 3000 ohms.Additionally, episodes with oversensing of noise on the ventricular channel were found, which included periods of greater than 14 seconds of asystole.As a result, the patient was admitted to the hospital and a new non-boston scientific rv lead was implanted with evidence of optimal electrical measurements on the pacing system analyzer, but when the physician connected this lead to the already implanted crt-p, no change in the pacing morphology could be observed on the electrocardiogram, and high out of range pacing impedance measurements and noise were present.Further troubleshooting was performed, an after manipulating the device, it was noted that the noise improved but it was being oversensed, and the pacing impedance was still high out of range, measuring 2400 ohms.Consequently, the physician made the decision to explant the crt-p device and a non-boston scientific product was implanted instead as a device header connection problem was suspected.The procedure was completed successfully, and no additional adverse patient effects were reported.The device is expected to be returned for analysis.
 
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.At this time, the product has not been returned.If the product is returned, analysis will be performed, and this report will be updated at that time.
 
Event Description
It was reported that this patient attended the clinic with symptoms of presyncope.Upon device interrogation, it was noted that this cardiac resynchronization therapy pacemaker (crt-p) system had triggered a lead safety switch (lss) due to a high out of range right ventricular (rv) pacing impedance measurements greater than 3000 ohms.Additionally, episodes with oversensing of noise on the ventricular channel were found, which included periods of greater than 14 seconds of asystole.As a result, the patient was admitted to the hospital and a new non-boston scientific rv lead was implanted with evidence of optimal electrical measurements on the pacing system analyzer, but when the physician connected this lead to the already implanted crt-p, no change in the pacing morphology could be observed on the electrocardiogram, and high out of range pacing impedance measurements and noise were present.Further troubleshooting was performed, an after manipulating the device, it was noted that the noise improved but it was being oversensed, and the pacing impedance was still high out of range, measuring 2400 ohms.Consequently, the physician made the decision to explant the crt-p device and a non-boston scientific product was implanted instead as a device header connection problem was suspected.The procedure was completed successfully, and no additional adverse patient effects were reported.The device is expected to be returned for analysis.Several attempts were made asking for product return for analysis.Evidence suggests that this device was sent to boston scientific, but further investigation to locate the device has been unsuccessful.If the device is returned in the future, technical analysis will be performed, and this report will be updated at that time.
 
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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 Key17980760
MDR Text Key326233286
Report Number2124215-2023-58552
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 Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/17/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberU228
Device Catalogue NumberU228
Device Lot Number780115
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/17/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2022
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;
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