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 INGENIO; IMPLANTABLE PULSE 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 INGENIO; IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number K172
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 07/17/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event or Problem Description
Boston scientific received information that this pacemaker was part of system revision due to infection.There were no additional adverse patient effects reported.The pacemaker was explanted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INGENIO
Common Device Name
IMPLANTABLE PULSE GENERATOR
Manufacturer (Section D)
GUIDANT CRM CLONMEL IRELAND
guidant ireland
clonmel, tipperary ireland
MDR Report Key7989393
Report Number2124215-2018-17329
Device Sequence Number19136124
Product Code LWP
UDI-Device Identifier00802526516818
UDI-Public(01)00802526516818(17)20161124
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/17/2018
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
Operator of Device Lay User/Patient
Device Expiration Date11/24/2016
Device Model NumberK172
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/17/2018
Initial Report FDA Received Date10/22/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
1298; 4024; 4456; 4568; 7741; K172; KDR403; L310
Outcome Attributed to Adverse Event Hospitalization; Life Threatening; Required Intervention;
Patient Age75 YR
-
-