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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 Over-Sensing (1438); Use of Device Problem (1670)
Patient Problem Injury (2348)
Event Date 03/09/2019
Event Type  Injury  
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete. This investigation will be updated should further information be provided.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had evidence of oversensing on the right atrial (ra) lead. The patient is pacemaker dependent and reported not feeling well. The physician was concerned of possible oversensing on the right ventricular (rv) channel but electrocardiograms (egm) were unavailable for all of the atrial tachy response (atr) episodes. Boston scientific technical services (ts) noted that this device will only store up to 10 atr episodes and of these 10 episodes, a maximum of 3 will have egm data available. The sensitivity was reprogrammed and the device remains in service.
 
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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 CLONMEL LIMITED
cashel road
,
clonmel
EI
Manufacturer Contact
timothy degroot
4100 hamline avenue north
,
saint paul, MN 55112
6515826168
MDR Report Key8512346
MDR Text Key141894951
Report Number2124215-2019-06198
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P030005/S113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/13/2020
Device Model NumberU125
Device Catalogue NumberU125
Device Lot Number708766
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 Received03/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/04/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/13/2019 Patient Sequence Number: 1
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