Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND INOGEN; IMPLANTABLE CHF GENERATOR
  • 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
 

GUIDANT CRM CLONMEL IRELAND INOGEN; IMPLANTABLE CHF GENERATOR Back to Search Results
Model Number G148
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Pericardial Effusion (3271)
Event Date 12/11/2014
Event Type  Injury  
Event Description
Boston scientific received information that a post implant echocardiogram revealed a small pericardial effusion.No adverse patient effects were reported.
 
Manufacturer Narrative
(b)(4).This product issue will be re-evaluated if additional details are received.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INOGEN
Type of Device
IMPLANTABLE CHF GENERATOR
Manufacturer (Section D)
GUIDANT CRM CLONMEL IRELAND
guidant ireland
clonmel, tipperary ireland
Manufacturer (Section G)
GUIDANT CRM CLONMEL IRELAND
guidant ireland
clonmel, tipperary ireland
Manufacturer Contact
sonali vasekar
4100 hamline ave. n
st. paul, MN 55112
6515824786
MDR Report Key4882531
MDR Text Key6263927
Report Number2124215-2015-06012
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
PMA/PMN Number
P010012/S341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 04/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date10/22/2016
Device Model NumberG148
Other Device ID NumberINOGEN X4 CRT-D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 04/21/2015
Initial Date FDA Received07/01/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/15/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
0693; G148; 4674; MISMATCH
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age61 YR
-
-