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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 08/01/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s lead was implanted upside-down on the patient¿s nerve. It is unclear how the physician made this determination. An implant card was received stating that patient underwent lead replacement surgery on (b)(6) 2014 due to lead failure. The explanted lead has not been returned to date.

 
Event Description

It was reported that the lead being placed on the nerve upside down was confirmed during lead replacement surgery. Further follow-up revealed that the patient requested that the vns be explanted due to ear pain. The patient's device was programmed off, but the patient requested explant. It was reported that despite the lead replacement. The patient claims to still have a buzzing noise along with severe constant ear pain. It was reported that device diagnostics have been within normal limits and there is no belief of device malfunction. There is no relationship of the vns to the patient't buzzing noise and ear pain. The patient underwent vns explant on 12/12/2014.

 
Manufacturer Narrative

 
Event Description

Additional information was received stating that the vns patient was referred for surgery to explant her generator. The patient reportedly was hearing a buzzing noise from her device. The patient¿s generator has not been explanted 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 Key4110421
Report Number1644487-2014-02428
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 08/26/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/23/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2014
Device MODEL Number304-20
Device LOT Number2727
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/01/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/14/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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