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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 U125
Device Problems High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877)
Patient Problems Headache (1880); Unspecified Infection (1930); Dizziness (2194)
Event Date 07/21/2017
Event Type  Injury  
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 this cardiac resynchronization therapy pacemaker (crt-p), left ventricular (lv) and another manufacturer's right ventricular (rv) lead exhibited high out of range pacing impedance measurements greater than 2,000 ohms resulting in activation of the lead safety switch (lss) feature. Review of stored device memory also noted several stored ventricular tachycardia (vt) episodes due to noise and oversensing on both leads that was felt to be consistent with oversensing related to the respiratory rate trend (rrt) feature. The patient was noted to be pacemaker dependent and experienced pacing inhibition for greater than 10 seconds of asystole. The patient also complained of symptoms of lightheadedness, dizziness and headaches. It was noted that the patient had recently been diagnosed with a sinus and respiratory infection, so it was unknown if the symptoms were related to the illness or the device and leads. A chest x-ray was performed and noted no obvious anomalies. Boston scientific technical services (ts) discussed programming rrt off. Programming changes were made to rv and lv lead sensitivity and monitoring will be continued. No adverse patient effects were reported. This product remains implanted and 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 Key7191784
MDR Text Key97294068
Report Number2124215-2017-20630
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
Report Date 10/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/22/2018
Device Model NumberU125
Other Device ID NumberVALITUDE
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 Received10/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2016
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: 01/15/2018 Patient Sequence Number: 1
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