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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U228
Device Problems High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Defective Device (2588); Ambient Noise Problem (2877); Device Operates Differently Than Expected (2913); Device Sensing Problem (2917)
Patient Problems Complaint, Ill-Defined (2331); Injury (2348)
Event Date 02/02/2018
Event Type  Injury  
Manufacturer Narrative
As no further information concerning this report is expected at this time, our investigation is complete. This investigation will be updated should further information be provided.
 
Event Description
Boston scientific received information that during a routine follow-up appointment, it was discovered that a lead safety switch occurred for this cardiac resynchronization therapy pacemaker (crt-p). The safety switch activated due to a single high out of range impedance measurement with a non-boston scientific right ventricular (rv) lead, which changed the lead configuration to unipolar. The patient was reported to be pre-syncopal and experienced symptoms of decompensation. The minute ventilation sensor was programmed off during this appointment. Data from the device memory was sent in to boston scientific technical services (ts) for review. Based on ts review, there are lead integrity concerns. The observed noise in episodes v12 and v13 did not represent typical minute ventilation oversensing; however, did show noise with oversensing and pacing inhibition. The longest pause was around 1700ms. The noise amplitudes were high enough to be sensed by the device. Ts discussed for the future follow-up appointments, obtaining an x-ray to assess any abnormality in the lead body, close monitoring of the lead impedances, sensing, and detection while the patient is doing arm movements, pocket manipulations, and posture changes. Ts also discussed running a real-time electrogram paper to document any noise reproduced by any action, and to complete all electrical measurements to determine if surgical intervention of the lead is necessary. Ts discussed the review of device data and recommendations with the field.
 
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 description for more information regarding the specific circumstances of this event.
 
Event Description
New information received indicates the minute ventilation (mv) sensor was deactivated by the signal artifact monitor (am) due to high out-of-range impedance measurements in both chambers. The field representative recommended programming to rate response features only. No adverse patient effects were reported. The device remains in service.
 
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Brand NameVISIONIST X4 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 degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key7354115
MDR Text Key102933152
Report Number2124215-2018-03218
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup
Report Date 09/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/16/2018
Device Model NumberU228
Device Catalogue NumberU228
Device Lot Number709548
Other Device ID NumberVISIONIST X4
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received08/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/20/2018 Patient Sequence Number: 1
Treatment
4076; 4677; U228
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