• 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 Over-Sensing (1438); Defective Device (2588); Ambient Noise Problem (2877)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/07/2018
Event Type  malfunction  
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 noise was observed on the right ventricular (rv) lead, which looks to be minute ventilation oversensing. This also happened to coincide with when dental work was performed. The health care professional (hcp) reported they could not get threshold & impedance measurements. The respiratory response trend was turned off and pacing was also now set to unipolar configuration. This device was included in the recent mv sensor signal oversensing advisory population.
 
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 Key7979967
MDR Text Key124176409
Report Number2124215-2018-15286
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 company representative
Reporter Occupation
Type of Report Initial
Report Date 08/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/01/2018
Device Model NumberU128
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received08/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0361-2018

Patient Treatment Data
Date Received: 10/18/2018 Patient Sequence Number: 1
Treatment
4675; 7742; U128
-
-