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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 302-30
Event Date 07/01/2014
Event Type  Malfunction  
Event Description

Clinic note dated (b)(6) 2015 note that the patient was undergoing surgery due neck pain at the left side of the neck. Surgical notes indicate that the surgery was unremarkable. It was reported that the patient did not have another vns system placed because the patient was "epilepsy free". The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.

 
Event Description

Analysis of the returned generator and lead was completed. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation cannot be made on that portion of the lead. There were no performance or any other type of adverse conditions found with the pulse generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

 
Event Description

Clinic notes were received dated (b)(6) 2015 that indicated that a patient implanted with a vns device has been experiencing pain at one of their lead "anchor" sites since he was last seen in (b)(6) 2014. The pain has persisted, the patient takes advil but is still able to complete daily activities. The patient was referred for surgery for "removal of the anchor. " additional information was received that reported they were having their vns removed although unclear if whole device or just the anchor. Their pain is reported to be located in their neck and caused by a disconnected lead. It is unknown whether their was any trauma that caused the event.

 
Manufacturer Narrative

 
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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 Key4588059
Report Number1644487-2015-04110
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 02/13/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2010
Device MODEL Number302-30
Device LOT Number200593
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/02/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/20/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/16/2007
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: 03/10/2015 Patient Sequence Number: 1
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