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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 Problem Battery Problem (2885)
Patient Problem Atrial Fibrillation (1729)
Event Date 01/15/2020
Event Type  malfunction  
Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted. The associated investigation determined that this device exhibited sensing of chronic high atrial rates which may impact battery longevity over time. Please refer to the description for more information regarding the specific circumstances of this event.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had tripped elective replacement indicator (eri) three months ago and had recently tripped to eri again. The data analysis confirmed that the device had tripped eri twice as it reverted to less than one-year remaining status. The device was consuming great deal of power due to high output setting and high atrial rate sensing as the device was in persistent atrial fibrillation. The boston scientific engineers believed that it may be too late to reprogram the device as it is unlikely that the device will revert out of eri again. To date, the device remains in service. No 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
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key10225791
MDR Text Key197990846
Report Number2124215-2020-10643
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/02/2018
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number703245
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 Received04/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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