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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 Over-Sensing (1438); Pacing Problem (1439); Device Displays Incorrect Message (2591); Ambient Noise Problem (2877)
Patient Problems Syncope (1610); Fall (1848)
Event Date 08/07/2018
Event Type  Injury  
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed. Interrogation of the device confirmed it was operating in safety core and that both brady and tachy therapy remained available. Review of device memory identified an error. The error resulted in software resets performed in an attempt to correct an identified memory inconsistency. The corrupted memory was corrected in the laboratory and the device reverted to normal operation. The cause of the memory inconsistency was not able to be determined through laboratory testing but was likely the result of exposure to radiation, either therapeutic or environmental.
 
Event Description
Boston scientific received information that the patient with this pacemaker was hospitalized after a syncopal episode that resulted in a fall. An electrocardiogram was obtained that showed pauses in pacing. Device interrogation revealed that the pacemaker had entered safety mode and was oversensing noise on the right ventricular (rv) channel. The oversensing led to pacing inhibition of up to seven seconds for this pacemaker dependent patient. The system was implanted on the left side and testing revealed that the noise could be recreated by moving the left arm. Boston scientific technical services (ts) was consulted and device replacement was recommended. A revision procedure was performed and this pacemaker was explanted and replaced. The rv lead is a competitor product. No additional adverse patient effects were reported.
 
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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 Key7981655
MDR Text Key124283535
Report Number2124215-2018-17864
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
Report Date 08/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/13/2020
Device Model NumberU125
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received08/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2018
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: 10/18/2018 Patient Sequence Number: 1
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