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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 Problems Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 03/02/2021
Event Type  Injury  
Event Description
It was reported that the patient with a cardiac resynchronization therapy pacemaker (crt-p) presented to (b)(6) hospital emergency room. Upon examination there were observations of intermittent loss of capture and pacing spikes on the hospital monitor. The patient requested to be transferred to (b)(6) hospital as she just recently moved. An interrogation was performed at (b)(6) and it was found the device was in safety mode and almost at elective replacement indicator (eri). Additionally, it was noted there was myopotential oversensing which resulted in five to six seconds of pacing inhibition. This prompted for an emergent device change out. The patient is therapy dependent. The device was explanted and replaced successfully. The device will be returned to boston scientific for device analysis. No additional 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 Key12113182
MDR Text Key260047028
Report Number2124215-2021-14185
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526536632
UDI-Public00802526536632
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/14/2021
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 Date09/13/2014
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number101875
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/05/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2018-2021

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