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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; IMPLANTABLE DEVICE
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BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; IMPLANTABLE DEVICE Back to Search Results
Model Number U128
Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)
Patient Problem Dizziness (2194)
Event Date 11/13/2020
Event Type  malfunction  
Event Description
It was reported that there was noise on the right ventricular (rv) lead (non-boston scientific product) and there was fluctuating high out-of-range impedance.A lead safety switch had occurred and the programming changed from bipolar to unipolar.The impedance had been stable since the switch; however, noise was still present and occurred with patient movement.There was also a signal artifact monitor (sam) episode due to sensing of the minute ventilation (mv) signal related to the respiratory rate trend (rrt) feature.The oversensing led to pacing inhibition with more than two seconds of asystole and the patient experienced occasional dizziness/lightheadedness.Technical services recommended further troubleshooting and programming the cardiac resynchronization therapy pacemaker (crt-p) system to unipolar pacing and bipolar sensing.The rrt was also turned off.At this time, this crt-p remains in service and no additional adverse patient effects were reported.
 
Event Description
It was reported that there was noise on the right ventricular (rv) lead (non-boston scientific product) and there was fluctuating high out-of-range impedance.A lead safety switch had occurred and the programming changed from bipolar to unipolar.The impedance had been stable since the switch; however, noise was still present and occurred with patient movement.There was also a signal artifact monitor (sam) episode due to sensing of the minute ventilation (mv) signal related to the respiratory rate trend (rrt) feature.The oversensing led to pacing inhibition with more than two seconds of asystole and the patient experienced occasional dizziness/lightheadedness.Technical services recommended further troubleshooting and programming the cardiac resynchronization therapy pacemaker (crt-p) system to unipolar pacing and bipolar sensing.The rrt was also turned off.At this time, this crt-p remains in service and 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.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.Additionally, this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection.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.Please see the description for more information regarding the specific circumstances of this event.
 
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Brand Name
VALITUDE X4 CRT-P
Type of Device
IMPLANTABLE DEVICE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key11136358
MDR Text Key225752433
Report Number2124215-2020-27769
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526559402
UDI-Public00802526559402
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 04/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/23/2019
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number717258
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/01/2020
Initial Date FDA Received01/07/2021
Supplement Dates Manufacturer Received01/20/2021
Supplement Dates FDA Received04/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age77 YR
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