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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

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CYBERONICS, INC. LEAD MODEL 303 Back to Search Results
Model Number 303-20
Event Date 08/13/2014
Event Type  Injury  
Event Description

It was reported that the vns patient was experiencing pain and possibly developed an infection at lead incision site. No further information has been received to date.

 
Event Description

It was identified that a duplicate report of this patient's infection was submitted in mfg report #: 1644487-2014-02448. This report will house any future information related to the infection. It was reported that the infection may have been related to the sutures from surgery, although surgery was over a year prior.

 
Manufacturer Narrative

Suspect medical device, corrected data: the initial report inadvertently reported the incorrect suspect device. Device manufacture date, corrected data: the initial report inadvertently reported the incorrect suspect device. Evaluation codes, corrected data: the initial report inadvertently did not report the device history records being reviewed and report the results and conclusion codes incorrectly. Manufacturer device history records were reviewed. A review of device history records showed that the lead met specifications for sterilization testing prior to distribution.

 
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Brand NameLEAD MODEL 303
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key4113036
Report Number1644487-2014-02440
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/27/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/24/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2016
Device MODEL Number303-20
Device LOT Number202132
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/13/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/15/2012
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: 09/24/2014 Patient Sequence Number: 1
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