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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 11/01/2014
Event Type  Injury  
Event Description

It was reported that the patient was seen by an ent and it was found that one of the leads is lying on the patient¿s vocal cord and causing redness and swelling. The patient was referred for a ct scan. It was reported that the physician would like the patient to undergo vns replacement. No known surgical interventions have been performed to date. No additional relevant information has been received to date.

 
Event Description

The explanted generator was returned on (b)(6) 2015. Analysis is underway but has not been completed.

 
Event Description

The generator reaching end of service was determined to be the result of normal battery depletion. The depletion was an expected event as determined by blc and battery voltage measurement. There were no performance or any other type of adverse conditions found with the pulse generator.

 
Manufacturer Narrative

 
Manufacturer Narrative

Device available for evaluation?, corrected data: no. The suspect device was not available for evaluation. Supplemental #2 report incorrectly reported that the device was for evaluation. Device evaluated by mfr? corrected data: not returned to mfr. The suspect device was not returned. Supplemental #2 report incorrectly reported that the device was returned.

 
Event Description

Additional information was received that the patient underwent generator replacement on (b)(6) 2014. Attempts for product return were made but the explanted generator has not been received to date.

 
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Brand NameLEAD MODEL 302
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 Key4294419
Report Number1644487-2014-03196
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/05/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/03/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2008
Device MODEL Number302-20
Device LOT Number016111
Was Device Available For Evaluation? No
Date Returned to Manufacturer03/16/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/13/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/28/2006
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: 12/03/2014 Patient Sequence Number: 1
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