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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION INVIVE PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number V173
Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Resultor Readings (1535); Battery Problem (2885)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2021
Event Type  Injury  
Manufacturer Narrative
If additional information is received a supplemental report will be submitted.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker displayed safety mode. A procedure was performed in which the device was explanted due to premature battery depletion. A new device was implanted and remains in service. No additional adverse patient effects were reported.
 
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Brand NameINVIVE
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, 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 Key12113982
MDR Text Key260285187
Report Number2124215-2021-15961
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/06/2022
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 Date01/13/2016
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number105474
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2014
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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