• 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 U128
Device Problems Electrical /Electronic Property Problem (1198); Over-Sensing (1438)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 03/31/2016
Event Type  malfunction  
Manufacturer Narrative
No additional information is available. If additional information becomes available the report will be updated at that time.
 
Event Description
Boston scientific received information that the clinician contacted boston scientific technical services (ts) and asked them to review the presenting electrogram (egm) on the remote monitoring system. Upon review ts found that it showed an extra signal on the right ventricular (rv) channel about 350 milliseconds after every paced marker. It was noted that there was not a similar signal on the left ventricular (lv) egm. Further review noted that this also occurred on the presenting egm from the day after implant. The rv automatic threshold egm was reviewed and the extra signal was not present. Ts stated that this could possibly be because the device is rv only pacing at that point. Although the patient was not symptomatic, the patient did report feeling the same way as prior to receiving the cardiac resynchronization therapy pacemaker (crt-p). The rv threshold appears appropriate and the lv impedance varies between 1170-1430. Ts discussed possible reasons for this to occur and suggested bring the patient in for evaluation. According to the field representative the patient has not been brought in for evaluation to date and the system remains in service.
 
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
sonali vasekar
4100 hamline ave. n
st. paul, MN 
6515824786
MDR Report Key5787489
MDR Text Key49375636
Report Number2124215-2016-08388
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
PMA/PMN Number
P030005/S113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 04/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/10/2017
Device Model NumberU128
Other Device ID NumberVALITUDE X4
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 Received04/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/10/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-