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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND ACCOLADE IMPLANTABLE PULSE GENERATOR

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GUIDANT CRM CLONMEL IRELAND ACCOLADE IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number U128
Device Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 03/30/2018
Event Type  malfunction  
Manufacturer Narrative
The product has been received for analysis. This report will be updated upon completion of analysis.
 
Event Description
Boston scientific received information that this cardiac resynchronization therapy pacemaker (crt-p) recorded an error indicative of low battery capacity during a pre-implant status. A request was made to have this device returned for analysis. The device was not implanted. No patient involvement.
 
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 and battery system fault were recorded. Electrical testing and analysis isolated the product performance issue to an anomaly in the radio frequency (rf) mics module. This anomaly resulted in high power usage that depleted the battery while still in pre-implant status.
 
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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 Key7650530
MDR Text Key112734330
Report Number2124215-2018-11691
Device Sequence Number1
Product Code NKE
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,Followup
Report Date 07/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/15/2018
Device Model NumberU128
Other Device ID NumberVALITUDE X4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received07/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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