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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 High impedance (1291); Pacing Problem (1439)
Patient Problem Atrial Tachycardia (1731)
Event Date 01/10/2018
Event Type  malfunction  
Manufacturer Narrative
At this time, the device remains in service. If additional information is received, this report will be updated.
 
Event Description
Boston scientific received information that this cardiac resynchronization therapy pacemaker (crt-p) triggered a lead safety switch due to left ventricular (lv)impedance measurements of greater than 2000 ohms. Additionally, lv pacing was being inhibited due to the patient¿s atrial tachycardia. The patient was started on medications for that. The lead would remain in unipolar configuration and the patient would continue to be monitored. No adverse patient effects were reported. The device remains in service.
 
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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 Key7350303
MDR Text Key102865656
Report Number2124215-2018-01916
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
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 01/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/19/2018
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 Received01/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/19/2016
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: 03/19/2018 Patient Sequence Number: 1
Treatment
(B)(4); (B)(4); (B)(4); MISMATCH
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