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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE IMPLANTABLE DEVICE

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BOSTON SCIENTIFIC CORPORATION INVIVE IMPLANTABLE DEVICE Back to Search Results
Model Number V173
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2021
Event Type  Injury  
Event Description
It was reported upon interrogation of this cardiac resynchronization therapy pacemaker (crt-p), the device was found to be in safety mode with limited functionality. Technical services (ts) recommended to replace the device and return it back for device analysis. At this time, the device remains in service. No adverse patient effects were reported.
 
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Brand NameINVIVE
Type of DeviceIMPLANTABLE DEVICE
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 Key12113199
MDR Text Key260427886
Report Number2124215-2021-13890
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,Followup
Report Date 04/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/05/2014
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number102438
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/07/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/03/2021 Patient Sequence Number: 1
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