• 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 U228
Device Problems Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/31/2018
Event Type  Injury  
Manufacturer Narrative
No further information has been provided to date. This report will be updated should additional information become available.
 
Event Description
Boston scientific received information that two episodes of right ventricular (rv) lead noise and oversensing were found stored to this cardiac resynchronization therapy pacemaker (crt-p) during in-clinic review following a previous av node ablation. The episodes were reviewed by boston scientific technical services (ts) who stated the noise appeared consistent with electromagnetic interference (emi). Instances of pacing inhibition and asystole were observed lasting up to approximately 4. 5 seconds though the patient was reportedly asymptomatic. Suggestions were provided for additional system testing to determine the cause. This system remains in service.
 
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 Description
Additional information was received indicating the patient presented for provocation testing during which noise could not be reproduced. The patient will continue with routine follow-up in addition to remote monitoring. No 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 Key7646809
MDR Text Key112626665
Report Number2124215-2018-11497
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 06/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/08/2019
Device Model NumberU228
Other Device ID NumberVISIONIST X4
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received06/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/08/2017
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: 06/28/2018 Patient Sequence Number: 1
Treatment
4674; 7742; U228
-
-