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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)

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BOSTON SCIENTIFIC CORPORATION INVIVE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) Back to Search Results
Model Number V173
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems Fatigue (1849); Device Overstimulation of Tissue (1991)
Event Date 05/29/2021
Event Type  Injury  
Manufacturer Narrative
This product is expected to be returned. If the product is returned, analysis would be performed and this report would be updated at that time.
 
Event Description
It was reported that for patient protection, this cardiac resynchronization therapy pacemaker switched into safety mode, a device status that permanently limits available therapy to specific settings. This condition was confirmed with a programmer interrogation. Technical services recommended device replacement and to understand it's condition it was advised to be returned and analyzed. Additional information was received stating that the patient was not tolerating the safety mode configuration, the patient felt diaphragmatic stimulation and fatigued with activity. This device was explanted, replaced and it is expected to be returned for analysis. No additional adverse patient effects were reported.
 
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Brand NameINVIVE
Type of DeviceCARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (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 Key12114018
MDR Text Key260422328
Report Number2124215-2021-16075
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 10/10/2021
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 Number101880
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/20/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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