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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC CRT-P V173 PACEMAKER GENERATOR PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC CRT-P V173 PACEMAKER GENERATOR PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number V173
Device Problems Use of Incorrect Control Settings (1126); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 05/08/2021
Event Type  Injury  
Event Description
Patient has a boston scientific v173 pacemaker, which reverted to safety mode and required urgent generator change. This is the fourth event of this type in our practice, the other three have been previously reported. Fda safety report id # (b)(4).
 
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Brand NameBOSTON SCIENTIFIC CRT-P V173 PACEMAKER GENERATOR
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key11929852
MDR Text Key254487943
Report NumberMW5101681
Device Sequence Number1
Product Code NKE
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberV173
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2021
Is the Reporter a Health Professional? Yes
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: 06/02/2021 Patient Sequence Number: 1
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