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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 05/13/2003
Event Type  Injury  
Event Description

On (b)(6) 2013, they physician reported that the patient had vocal cord paralysis, but it was improving. He also noted that the surgeon had reported to him that the patient was having swallowing difficulties and that the patient's jugular vein was nicked during implant surgery. It was unknown if the patient had been evaluated by an ear nose throat doctor. The patient's device was turned on sometime after surgery, but the exact date was unknown. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has bene received.

 
Event Description

Additional information was received from the physician in response to the good faith attempts. The physician confirmed that the jugular was nicked during lead removal and repaired. The vns was activated the same day, as is their standard procedure, at minimal settings and not the patient's previous settings. Per the telephone, the patient appeared hoarse continuously several days after the lead replacement, but this resolved. The physician interpreted this as transient vocal cord paralysis related to lead removal from the nerve. The physician believes that the patient is not well. No further information was provided.

 
Manufacturer Narrative

Previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Previously submitted mdr indicated that the patient was the user; however, this should be the medical professional.

 
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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 Key3191517
Report Number1644487-2013-01936
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/30/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2017
Device MODEL Number304-20
Device LOT Number202415
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/20/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/25/2013
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: 06/26/2013 Patient Sequence Number: 1
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