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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 05/19/2012
Event Type  Injury  
Event Description

On (b)(6) 2012, the vns patient reported that she has been experiencing some post-operation surgery effects. The patient was implanted on (b)(6) 2012. The patient stated that the vns is protruding, the patient's voice is altered and is high, and the patient's head is turned away from incision mark 4 and there is redness around the site. The patient's mother stated that the patient had to go back to the hospital overnight on (b)(6) 2012 due to pain as the patient had a hematoma and could not turn his head to the left. The patient's voice was still impaired. The patient's mother stated that the patient is doing better now. The physician later stated that they have no explanation for why the patient couldn't turn his head to the left however; the physician did not believe it was due to vns. The pain is located on the right side. No interventions were planned or taken and on (b)(6) 2012 the device was turned on. The physician does not believe the pain is related to vns. The physician clarified that there is no protrusion; the patient's mother was worried because the events occurred right after surgery, but the physician stated that the patient is healing quite nicely. The patient's implanted product information has been requested from the implanting hospital but it has not been received to date.

 
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Brand NameLEAD MODEL 304
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 Key2620968
Report Number1644487-2012-01528
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/22/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/19/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2015
Device MODEL Number304-20
Device LOT Number2903
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received03/10/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/05/2011
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: 06/19/2012 Patient Sequence Number: 1
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