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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAMERON HEALTH S-ICD SYSTEM; IMPLANTABLE LEAD - PROD CODE NVY

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CAMERON HEALTH S-ICD SYSTEM; IMPLANTABLE LEAD - PROD CODE NVY Back to Search Results
Model Number 3010
Device Problem Material Erosion (1214)
Patient Problems Unspecified Infection (1930); Pocket Erosion (2013)
Event Date 12/30/2013
Event Type  Injury  
Event Description
Boston scientific received info from a product experience report that this device and electrode were extracted due to erosion/infection.The pt did received antibiotics.No complications or irreparable injury was reported.
 
Manufacturer Narrative
As no further info concerning this report is expected, our investigation is complete.This investigation will be updated should further info be provided.
 
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Brand Name
S-ICD SYSTEM
Type of Device
IMPLANTABLE LEAD - PROD CODE NVY
Manufacturer (Section D)
CAMERON HEALTH
san clemente CA
Manufacturer (Section G)
CAMERON HEALTH INC
905 calle amanecer
suite 300
san clemente CA 92673
Manufacturer Contact
ingrid matte
4100 hamline avenue n
st. paul, MN 55112
6515826994
MDR Report Key3595400
MDR Text Key4066524
Report Number3009448963-2013-00145
Device Sequence Number1
Product Code NVY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P11042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 12/30/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date12/01/2014
Device Model Number3010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received 12/30/2013
Initial Date FDA Received01/14/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2012
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
1010
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age59 YR
Patient Weight55
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