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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); Capturing Problem (2891)
Patient Problems Muscle Stimulation (1412); No Known Impact Or Consequence To Patient (2692)
Event Date 09/27/2016
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 due to the markers on the electrogram (egm), there was concern over possible left ventricular (lv) lead loss of capture (loc). It was noted that the output had been decreased at the previous visit due to chest wall stimulation. The other manufacturer's lv lead threshold measurements had increased. The patient was noted to be ventricular dependent, but was pacing in the right ventricle without issue and there were no adverse patient effects. The patient was brought back into the clinic where they repeated lv threshold testing and changed the sensing vector. Two months later the patient contacted the clinic with complaints of feeling "a little bit off. " review of the remote home monitoring data found that there was now lv loc in the previously programmed vector. Boston scientific technical services (ts) was consulted and suggested bringing the patient in to test other vectors and possibly increase the output. The clinic opted to have the patient performed another transmission which showed lv capture. The physician has opted to continue to monitor the patient for now and will have the patient come into the clinic when normally scheduled. The patient was asymptomatic. The cardiac resynchronization therapy pacemaker (crt-p) and lv lead remain 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 Key7496206
MDR Text Key107683876
Report Number2124215-2018-08293
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 01/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2017
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 Received01/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/14/2015
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: 05/08/2018 Patient Sequence Number: 1
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