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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND S-ICD SYSTEM; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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GUIDANT CRM CLONMEL IRELAND S-ICD SYSTEM; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number A209
Device Problems High impedance (1291); Device Operates Differently Than Expected (2913)
Patient Problem Ventricular Tachycardia (2132)
Event Date 01/07/2017
Event Type  malfunction  
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 the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) was in ventricular tachycardia (vt).An appropriate shock was delivered which successfully converted the rhythm, however the patient went back into a vt.A second shock was delivered which accelerated the rhythm into ventricular fibrillation (vf) with a third shock successfully converted the vf.High shock impedance measurements were noted but remained within range.An x-ray was performed and the system position looked appropriate.The device was later explanted and replaced with a transvenous implantable cardioverter defibrillator (icd).No adverse patient effects were reported.
 
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Brand Name
S-ICD SYSTEM
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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 Key7665387
MDR Text Key113284201
Report Number2124215-2018-12138
Device Sequence Number1
Product Code LWS
UDI-Device Identifier00802526544101
UDI-Public00802526544101
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 04/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/25/2017
Device Model NumberA209
Other Device ID NumberEMBLEM S-ICD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 04/30/2018
Initial Date FDA Received07/05/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/25/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age54 YR
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