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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 Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems Fall (1848); Pain (1994); Syncope/Fainting (4411)
Event Date 01/24/2021
Event Type  Injury  
Manufacturer Narrative
This product is being evaluated in our post market quality assurance laboratory. This report will be updated when evaluation is complete.
 
Event Description
It was reported that this patient had a history of falls and syncope. The patient had recently undergone a surgery for an unspecified reason. The patient presented to the hospital after experiencing multiple syncopal events over the past week. The patient was admitted to the hospital and interrogation revealed the device was in safety mode. A review of the device data identified pacing inhibition of six to eight seconds. The patient had been in pain due to the recent surgery and had been moving around which resulted in noise, oversensing and the observed inhibition. A revision procedure was performed and this system was removed from service and returned for testing. 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 Key11767334
MDR Text Key248777098
Report Number2124215-2021-11621
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
Type of Report Initial
Report Date 05/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/17/2016
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number107004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2014
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: 05/03/2021 Patient Sequence Number: 1
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