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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); Pocket Stimulation (1463); Low impedance (2285); Defective Device (2588)
Patient Problem Muscle Stimulation (1412)
Event Date 04/27/2018
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 a left ventricular (lv) lead revision procedure was performed due to pocket stimulation. It was noted that the day prior to the procedure the right ventricular (rv) lead had been programmed to unipolar configuration due to low pacing impedance measurements. The rv lead was also programmed sub threshold at that time. It was noted that the lv and rv leads were inspected under x-ray in the lab and found to be in good condition. Following the lv lead revision procedure noise was noted on the rv channel. Since the rv lead continued to exhibit low impedance measurements around 201 ohms and loss of capture (loc), another revision procedure was performed where the rv lead was surgically abandoned and successfully replaced. The crt-p remains in service and 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 Key7725528
MDR Text Key115189243
Report Number2124215-2018-13351
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 04/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2019
Device Model NumberU128
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received04/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/14/2017
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: 07/27/2018 Patient Sequence Number: 1
Treatment
4470; 4671; H120; MISMATCH; U128
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