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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U128
Device Problem Premature Discharge of Battery (1057)
Patient Problem No Code Available (3191)
Event Date 08/31/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). At this time, the product has not been returned. If the product is returned, analysis will be performed and this report would be updated.
 
Event Description
It was reported that during a routine implant procedure this cardiac resynchronization therapy pacemaker (crt-p) device, recorded a code 1003, a low voltage alert, pre-implant. A different device, of the same model, was implanted. The device is expected to be returned for analysis. No adverse patient effects were reported.
 
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Brand NameVALITUDE X4 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 Key10681622
MDR Text Key211461126
Report Number2124215-2020-20718
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup
Report Date 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/04/2020
Device Model NumberU128
Device Catalogue NumberU128
Device Lot Number735321
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/19/2018
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: 10/14/2020 Patient Sequence Number: 1
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