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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION VALITUDE X4 PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number U128
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Failure of Implant (1924)
Event Date 07/26/2021
Event Type  Injury  
Event Description
Pt#: (b)(6) underwent implantation of a bi-v pacemaker on (b)(6) 2016. Patient is noted to have a pacemaker malfunction and was deemed appropriate for the performance of pacemaker generator change. The device that was explanted is a boston scientific valitude u128.
 
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Brand NameVALITUDE X4
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key12336738
MDR Text Key267261941
Report NumberMW5103300
Device Sequence Number1
Product Code NKE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU128
Device Lot Number304756
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/17/2021 Patient Sequence Number: 1
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