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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 Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877); Material Integrity Problem (2978)
Patient Problem Dizziness (2194)
Event Date 12/27/2017
Event Type  malfunction  
Manufacturer Narrative
No further information has been provided to date. This report will be updated should additional information become available.
 
Event Description
Boston scientific received information that this cardiac resynchronization therapy pacemaker (crt-p) and competitor right ventricular (rv) lead exhibited myopotential oversensing resulting in approximately 3 seconds of pacing inhibition. The noise occurred while the patient was carrying a heavy object and resulted in dizziness. Noise was reproducible when the patient mimicked the movement. Lead measurements were within normal limits and stable, however, insulation damage was still suspected. Boston scientific technical services (ts) provided programming recommendations. No adverse patient effects were reported. This system 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 Key7238763
MDR Text Key98997358
Report Number2124215-2018-02353
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 Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 12/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/10/2018
Device Model NumberU128
Other Device ID NumberVALITUDE X4
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received12/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2016
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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