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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPERATION BOSTON SCIENTIFIC V173 PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number V173
Device Problems Pacing Intermittently (1443); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Failure of Implant (1924); Syncope/Fainting (4411)
Event Date 04/12/2021
Event Type  Injury  
Event Description
Boston scientific v173 pacer s/n (b)(4) implanted on (b)(6) 2013 with normal lead function on prior check, had a fatal error, reverted to backup pacing. Patient presented w/ recurrent syncope, and acute pacemaker failure with intermittent failure to output requiring transcutaneous pacing and emergent generator change. We have seen two other patients with similar error messages in this model pacemaker all occurring within the last year of battery longevity, although these patients did not suffer syncope. Fda safety report id # (b)(4).
 
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Brand NameBOSTON SCIENTIFIC V173
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPERATION
MDR Report Key11669611
MDR Text Key245838820
Report NumberMW5100783
Device Sequence Number1
Product Code NKE
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberV173
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2021
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: 04/14/2021 Patient Sequence Number: 1
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