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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)

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BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) Back to Search Results
Model Number U128
Device Problems False Positive Result (1227); High impedance (1291); Over-Sensing (1438)
Patient Problem Asystole (4442)
Event Date 08/13/2020
Event Type  malfunction  
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 intermittent increases in impedance measurements. Engineering analysis and testing of returned products has identified that any repeated, small movements of the lead terminal ring can create wearing of the lead terminal ring and generate microscopic particles, which may accumulate and oxidize over time. This can impact the connection between the spring contact and the lead ring, resulting in intermittent changes in impedance measurements. Please refer to the description field for more information regarding the specific circumstances of this event. This device was included in the minute ventilation sensor signal oversensing advisory population.
 
Event Description
It was reported that the right ventricular (rv) and left ventricular (lv) leads recorded high out of range (oor) impedances greater than 3000 ohms and declared a lead safety switch for both leads on may 8th, 2021. Additionally, upon review of this cardiac resynchronization therapy pacemaker (crt-p) logbook, technical services (ts) noted a signal artifact monitor (sam) episode back in aug, 2020, with minute ventilation (mv) oversensing in the rv channel, the feature was deactivated by the sam, however, no oor impedances were noted during this sam episode. The patient is pacemaker dependent and experienced asystole for no longer than 2 seconds, however, the patient did not report experiencing any symptoms. The crt-p logbook also recorded 2 prior sam episodes due to oversensing of atrial fibrillation (af). The crt-p system was checked with isometrics and pocket manipulations and no noise was produced, however, there was an oor rv lead impedance value. Ts discussed the possible causes for the clinical observations. The crt-p system was already reprogrammed and ts recommended further reprogramming options. The rv lead is a non-boston scientific product. No additional adverse patient effects were reported. Additional information from the field representative indicates that the rv and lv leads were reprogrammed and there are no further plans for this patient apart from continue to monitor. The patient has not been further evaluated and there were no additional adverse patient effects.
 
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Brand NameVALITUDE X4 CRT-P
Type of DeviceCARDIAC 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 Key12113335
MDR Text Key260479503
Report Number2124215-2021-16711
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/18/2020
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number738678
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 Received08/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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