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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND DYNAGEN; IMPLANTABLE CHF GENERATOR
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GUIDANT CRM CLONMEL IRELAND DYNAGEN; IMPLANTABLE CHF GENERATOR Back to Search Results
Model Number G158
Device Problems Pacing Problem (1439); Failure to Convert Rhythm (1540); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/15/2018
Event Type  malfunction  
Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
 
Event Description
Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) patient had an abrupt, unstable atrial fibrillation (af) rhythm that was 1 to 1.The rhythm became stable.Then 2 more episodes occurred the same way.Both became stable then got atp that accelerated into ventricular fibrillation (vf).The rhythm was shocked back into fast at that was in the ventricular tachycardia (vt) zone.In the last episode, more inappropriate shocks were then delivered, exhausting therapy.Upon review of the episodes, the device thought that the rhythm was af with vt and boston scientific technical services (ts) suggested turning off the af feature or to consider using some rhythm identifiers.It was also noted that the patient was pretty sick and dehydrated.The physician wanted to turn on the rhythm identifier feature and the patient will be monitored.No adverse patient effects were reported.
 
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Brand Name
DYNAGEN
Type of Device
IMPLANTABLE CHF 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 Key7646702
MDR Text Key112634075
Report Number2124215-2018-11488
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534904
UDI-Public00802526534904
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 05/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date12/05/2019
Device Model NumberG158
Other Device ID NumberDYNAGEN X4 CRT-D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received05/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/05/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
0293; 4674; 7741; G158
Patient Age62 YR
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