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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION INVIVE PULSE GENERATOR, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number V173
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2021
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be operating in safety mode. The device was subsequently explanted and replaced. No additional adverse patient effects were reported. At this time, the product has not been returned. If the product is returned, analysis will be performed and this report would be updated at that time.
 
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Brand NameINVIVE
Type of DevicePULSE GENERATOR, 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 Key12701659
MDR Text Key278523731
Report Number2124215-2021-32548
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S079
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/30/2015
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number102878
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 Received09/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/06/2013
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: 10/26/2021 Patient Sequence Number: 1
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