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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 Device Displays Incorrect Message (2591); Human-Device Interface Problem (2949)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/20/2018
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode indicating that three device faults had occurred. Immediate device replacement was recommended. The crt-p was explanted and returned for analysis. 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 CLONMEL LIMITED
cashel road
,
clonmel
EI
Manufacturer Contact
timothy degroot degroot
4100 hamline avenue north
,
saint paul, MN 55112
6515826168
MDR Report Key8179957
MDR Text Key130870549
Report Number2124215-2018-62382
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/05/2014
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number100371
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2012
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: 12/19/2018 Patient Sequence Number: 1
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