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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U125
Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); High Capture Threshold (3266)
Patient Problems Syncope (1610); Bradycardia (1751); Fall (1848); Head Injury (1879)
Event Date 10/08/2019
Event Type  Injury  
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. Please see the description for more information regarding the specific circumstances of this event. This device was included in the recent minute ventilation sensor signal oversensing advisory population.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) patient presented to the emergency room after experiencing syncope causing the patient to fall and hit their head. The device was interrogated and found loss of capture on both other manufacturer right ventricular and left ventricular leads. There were observations of fluctuating high impedances and high thresholds causing the loss of capture. Due to the patient condition they did not try to reproduce any noise. The device was reprogrammed to unipolar pace/bipolar sense, and impedance and thresholds came back down. When checking yesterday, it appeared that the minute ventilation sensor was sensing the high impedances creating noise (not oversensed), however it was mitigated by turning the rate response trend feature off. Technical services discussed performing additional troubleshooting focused on clavicular region. The patient had hit their head when they fell and a ct scan was performed, however the patient was doing much better the following day. The device system remains in-service. No additional adverse patient effects were reported.
 
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Brand NameVALITUDE 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 Key9546823
MDR Text Key173779453
Report Number2124215-2019-24772
Device Sequence Number1
Product Code NKE
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
Reporter Occupation
Type of Report Initial
Report Date 01/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/27/2019
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number706620
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/09/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial
Removal/Correction NumberZ-0355-2018

Patient Treatment Data
Date Received: 01/03/2020 Patient Sequence Number: 1
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