• 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 ACCOLADE 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 ACCOLADE IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number U125
Device Problems High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877)
Patient Problem Syncope (1610)
Event Date 05/22/2018
Event Type  Injury  
Manufacturer Narrative
At this time, the product remains in-service. If additional information is received, this report will be updated.
 
Event Description
Boston scientific received information that this cardiac resynchronization therapy pacemaker (crt-p) and right ventricular (rv) lead had in-range spikes in impedance, where on two occasions it had caused respiratory trend oversensing with pacing inhibition greater than two seconds. The most recent episode caused the patient to become syncopal. The thresholds were within normal limits. The rrt trends were turned off in response. The system remains in-service. No additional adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACCOLADE
Type of DeviceIMPLANTABLE PULSE 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
tim degroot
4100 hamline ave. n
st. paul, MN 
6515826168
MDR Report Key7725909
MDR Text Key115207011
Report Number2124215-2018-13200
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/19/2018
Device Model NumberU125
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received06/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/19/2016
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: 07/27/2018 Patient Sequence Number: 1
Treatment
4136; 4137; 4457; 4554; H120; S606; U125
-
-