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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 Consequences Or Impact To Patient (2199)
Event Date 10/07/2017
Event Type  Injury  
Manufacturer Narrative
At this time, the product has not been returned. If the product is returned, analysis will be performed and this report would be updated at that time.
 
Event Description
Boston scientific received information that this cardiac resynchronization therapy pacemaker (crt-p) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity. Data analysis showed the battery appeared to be depleting more quickly than expected. As a result, this crt-p was explanted and replaced. No additional adverse patient effects were reported.
 
Manufacturer Narrative
This cardiac resynchronization therapy pacemaker (crt-p) 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(s).
 
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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 Key7407094
MDR Text Key104694737
Report Number2124215-2018-01907
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/03/2019
Device Model NumberU128
Other Device ID NumberVALITUDE X4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received02/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2017
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: 04/09/2018 Patient Sequence Number: 1
Treatment
4469; 4470; 4543; 4549; 4674; 7740; 7741; 7742; U128; V273
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