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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND CONTAK RENEWAL TR IMPLANTABLE CHF GENERATOR

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GUIDANT CRM CLONMEL IRELAND CONTAK RENEWAL TR IMPLANTABLE CHF GENERATOR Back to Search Results
Model Number H140
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)
Event Date 01/15/2010
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 one month post implant the patient implanted with this product presented to the wound clinic with redness around pocket area with drainage. Surgical intervention was performed and the system was extracted. An allergy test confirmed that the patient is allergic to chromium and nickel. There were no additional adverse effects reported.
 
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Brand NameCONTAK RENEWAL TR
Type of DeviceIMPLANTABLE 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
sonali vasekar
4100 hamline ave. n
st. paul, MN 
6515824786
MDR Report Key6019109
MDR Text Key57047596
Report Number2124215-2016-12787
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 07/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/10/2011
Device Model NumberH140
Other Device ID NumberCONTAK RENEWAL TR2
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 Received07/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2009
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: 10/11/2016 Patient Sequence Number: 1
Treatment
0158; 1788TC; 4096; 4543; H140; P107
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