• Decrease font size
  • Return font size to normal
  • Increase font size
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)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION INVIVE PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number V173
Device Problems Off-Label Use (1494); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems Muscle Stimulation (1412); Device Overstimulation of Tissue (1991); No Code Available (3191)
Event Date 01/12/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). The product has been received for analysis. This report will be updated upon completion of analysis.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode. The device as nearing elective replacement indicator (eri) and the patient had weekly radiation treatments on the right side of her neck. The patient was also experiencing diaphragmatic stimulation. It was noted that the patient was pacer dependent. This crt-p was explanted and replaced. No additional adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11232816
MDR Text Key228832697
Report Number2124215-2021-02032
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,Followup
Report Date 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/17/2015
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number103584
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2013
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: 01/26/2021 Patient Sequence Number: 1
-
-