• 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 Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)
Patient Problem No Patient Involvement (2645)
Event Date 02/23/2017
Event Type  malfunction  
Manufacturer Narrative
This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory. Review of the device memory indicated that a telemetry system fault was recorded. The device case was opened to facilitate analysis of the internal components. Electrical testing and analysis isolated the product performance issue to an anomaly in the radio frequency (rf) mics module. This anomaly resulted in reported clinical observation.
 
Event Description
Boston scientific received information that this device was interrogated pre-implant. During interrogation, an error code was noted for voltage too low for remaining capacity. A save to disk was sent in for engineering analysis. Error codes related to the device's telemetry function were noted. The device was not to be implanted and was returned for analysis.
 
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 Key6694385
MDR Text Key79303487
Report Number2124215-2017-11208
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526559402
UDI-Public(01)00802526559402(17)20181122
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 04/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/22/2018
Device Model NumberU128
Other Device ID NumberVALITUDE X4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received04/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-