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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC BIPOL LEAD MODEL 300

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CYBERONICS INC BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Device Problem Insufficient Information (3190)
Patient Problem Staphylococcus Aureus (2058)
Event Date 05/01/2015
Event Type  Injury  
Event Description
It was reported that the patient underwent lead explant due to a staphylococcus aureus infection.The patient's last known neurologist reported that the patient had not been seen since (b)(6) 2013 and that the patient's mother was who notified him of the explant.The physician reported that no additional information was known regarding the infection.Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed.Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
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Brand Name
BIPOL LEAD MODEL 300
Type of Device
LEAD
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key4922409
MDR Text Key6016190
Report Number1644487-2015-05204
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/24/2015
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 Date06/30/2003
Device Model Number300-20
Device Lot Number3714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 06/24/2015
Initial Date FDA Received07/17/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2001
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 Outcome(s) Required Intervention;
Patient Age23 YR
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