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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 Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877); Device Operates Differently Than Expected (2913)
Patient Problems Syncope (1610); Fall (1848); Complaint, Ill-Defined (2331)
Event Date 10/02/2017
Event Type  malfunction  
Event Description
Additional information was received that two weeks later the patient presented to the emergency room with syncope for an unknown reason. It was also noted that the atrial counters showed 100 percent atrial paced as the atrial port on the crt-p was plugged. (b)(4) technical services (ts) reviewed and determined that run all tests may have been commanded as there was an atrial impedance measurement of 3000 ohms. Further discussion with the physician also found that the previous concern over the back up pace not capturing was no longer an issue and they believed the device to be operating as intended. The pacemaker and rv lead remain in service and no additional adverse patient effects were reported.
 
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete. This investigation will be updated should further information be provided.
 
Event Description
Boston scientific received information that there was a high rate event stored. Boston scientific technical services (ts) was consulted and discussed that there was oversensing of the minute ventilation signal with pacing inhibition for this pacemaker and another manufacturer's right ventricular (rv) lead. It was noted that the patient had an underlying rate and the episode only lasted for one and a half seconds. Ts discussed turning of minute ventilation. However the physician stated that the patient needed this feature. The physician opted to program off the respiratory rate response trend and will continue to monitor the patient. Additional information was received that the patient had fallen two days before going to the hospital. Review of the remote interrogation the day after the emergency room visit found rv loss of capture (loc). There was a concern that the back up pace also did not capture. Boston scientific technical services (ts) was consulted and discussed that the electrogram (egm) was flat due to blanking in the device and that the back up pace is designed to capture at 5 volts. Ts discussed that if there was concern over the back up pace not capturing, then the auto capture feature should be programmed off in the cardiac resynchronization therapy pacemaker (crt-p). The crt-p remains in service and no adverse patient effects were reported.
 
Event Description
Additional information was received that the crt-p and rv lead exhibited an increase in impedance from approximately 550 ohms to 650 ohms around the time the programming was changed to unipolar configuration.
 
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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 Key7189446
MDR Text Key100273790
Report Number2124215-2017-19586
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 health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/23/2019
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 Received12/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2017
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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