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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P; IMPLANTABLE DEVICE
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BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P; IMPLANTABLE DEVICE Back to Search Results
Model Number U125
Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438)
Patient Problem Syncope (1610)
Event Date 10/12/2020
Event Type  Injury  
Event Description
It was reported that boston scientific technical services (ts) received a call from a health care professional (hcp) about loss of capture with nine seconds of asystole and variable impedances within normal limits on the right ventricular (rv) and left ventricular (lv) leads.The patient was in the hospital because of an ablation procedure they had done the day before.The patient experienced some presyncope.It was noted that the signal artifact monitor (sam) had disabled the device's minute ventilation (mv) sensor.Ts suspected a spring contact issue, programming options were discussed and the device was reprogrammed.It was recommended to monitor the patient for twenty-four hours post programming changes.This device was included in the recent minute ventilation sensor signal oversensing advisory population, which ts discussed with the hcp.The device and leads remain in service.No additional adverse patient effects were reported.
 
Event Description
It was reported that boston scientific technical services (ts) received a call from a health care professional (hcp) about loss of capture with nine seconds of asystole and variable impedances within normal limits on the right ventricular (rv) and left ventricular (lv) leads.The patient was in the hospital because of an ablation procedure they had done the day before.The patient experienced some presyncope.It was noted that the signal artifact monitor (sam) had disabled the device's minute ventilation (mv) sensor.Ts suspected a spring contact issue, programming options were discussed and the device was reprogrammed.It was recommended to monitor the patient for twenty-four hours post programming changes.This device was included in the recent minute ventilation sensor signal oversensing advisory population, which ts discussed with the hcp.The device and leads remain in service.No additional adverse patient effects were 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 malfunction 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'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.
 
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Brand Name
VALITUDE CRT-P
Type of Device
IMPLANTABLE DEVICE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key11103883
MDR Text Key224759508
Report Number2124215-2020-24784
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526559389
UDI-Public00802526559389
Combination Product (y/n)N
PMA/PMN Number
P030005/S113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/04/2017
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number100743
Was Device Available for Evaluation? No
Date Manufacturer Received12/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-0360-2018
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age16 YR
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