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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 Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Asystole (4442)
Event Date 09/28/2021
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode. It was noted the device exhibited noise and pacing inhibition in which the patient experienced asystole of greater than 2 seconds. The patient was then hospitalized. Additionally, it was noted the left ventricular (lv) exhibited loss of capture. Technical services recommended replacing the device. Subsequently, the device was explanted and replaced successfully and the lv lead was surgically abandoned. 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 Key12661398
MDR Text Key277345662
Report Number2124215-2021-30924
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 Other Health Care Professional
Type of Report Initial
Report Date 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/13/2014
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number100972
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 Received09/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/19/2012
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: 10/19/2021 Patient Sequence Number: 1
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