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 ALTRUA; 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 ALTRUA; IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number S201
Medical Device Problem Code Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/15/2017
Type of Reportable Event Malfunction
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's battery showed less than six months with magnet rate of ninety.The health care professional (hcp) asked for a more precise estimate.The boston scientific technical services (ts) discussed elective replacement indicator (eri) and the device behavior when it reached eri.An attempt to obtain additional pertinent information was unsuccessful.To date, this pacemaker remains in service.No adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ALTRUA
Common Device Name
IMPLANTABLE PULSE GENERATOR
Manufacturer (Section D)
GUIDANT CRM CLONMEL IRELAND
guidant ireland
clonmel, tipperary ireland
MDR Report Key6936999
Report Number2124215-2017-15753
Device Sequence Number1523368
Product Code LWP
UDI-Device Identifier00802526484384
UDI-Public00802526484384
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 08/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date09/28/2011
Device Model NumberS201
Other Device ID NumberALTRUA 20
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 08/15/2017
Initial Report FDA Received Date10/10/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-