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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND INOGEN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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GUIDANT CRM CLONMEL IRELAND INOGEN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number D142
Device Problem Pocket Stimulation (1463)
Patient Problem Muscle Stimulation (1412)
Event Date 02/23/2017
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 the implantable cardioverter defibrillator (icd) was explanted due to muscle stimulation.No additional adverse patient effects were reported.
 
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Brand Name
INOGEN
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 
6515824786
MDR Report Key6526095
MDR Text Key73835150
Report Number2124215-2017-07330
Device Sequence Number1
Product Code LWS
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 Physician
Type of Report Initial
Report Date 03/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/08/2018
Device Model NumberD142
Other Device ID NumberINOGEN EL ICD
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Manufacturer Received03/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/08/2016
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
0295; D142; MISMATCH
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age41 YR
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