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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 Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 09/14/2020
Event Type  malfunction  
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed. A high current drain was detected. Detailed analysis confirmed the identified high current drain was a result of compromised capacitors. This resulted in the observed premature battery depletion. It was determined that the capacitors were compromised due to the presence of excess hydrogen in the device case. Boston scientific has issued a field safety notice regarding a subset of pacemakers in the accolade product family that has an elevated potential of exhibiting this behavior. This particular device is included in the hydrogen induced premature depletion advisory population.
 
Event Description
It was reported that this device was returned for analysis with no allegation. This device exhibited an increased power consumption due to leaky battery capacitors. No patient involvement.
 
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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 Key11276913
MDR Text Key230189991
Report Number2124215-2020-29258
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526536632
UDI-Public00802526536632
Combination Product (y/n)N
PMA/PMN Number
P030005/S079
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial
Report Date 02/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/18/2015
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number105023
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/26/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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