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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 303-20
Event Date 02/01/2013
Event Type  Malfunction  
Event Description

Reporter indicated intermittent high lead impedance was noted for a patient who recently had vns generator replacement on (b)(6) 2013. The patient had no known trauma. The patient is also experiencing painful stimulation at the electrode site in the neck. X-rays were reviewed by the manufacturer. The electrodes are visualized at approximately t1 and are in alignment; the electrodes are implanted lower than what is usually seen. The generator is implanted in the left axilla. This is much more lateral than what is normally seen. The view does not allow full assessment of the lead pin insertion. The lead wire is intact at the lead pin. The filter feedthroughs are intact. There is a small amount of lead behind the generator that cannot be assessed. The cause of the high lead impedance is unknown at this time, but may be due to inadequate pin insertion or a lead fracture. Attempts for additional information are in progress.

 
Event Description

Additional x-rays were reviewed by the manufacturer. The lead pin did not appear to be fully inserted. No additional anomalies were noted. The surgeon indicated he felt the lead pin had been fully inserted as two audible clicks were heard when tightening the setscrew. However, the possibility of a lead fracture may also exist. Reporter indicated the patient was also having increased seizures and that the plan of care is to have vns revision surgery; however, this has not occurred to date.

 
Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a serious injury.

 
Event Description

Manufacturer review of the device history records for the vns lead and generator confirmed both devices passed all final testing prior to distribution.

 
Manufacturer Narrative

 
Event Description

Reporter indicated the patient had vns lead pin reinsertion surgery performed on (b)(6) 2013. After the lead pin was reinserted into the generator header, diagnostics were within normal limits (3218 ohms). No new devices were implanted.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of generator.

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2993250
Report Number1644487-2013-00633
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/15/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/07/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2013
Device MODEL Number303-20
Device LOT Number2526
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/30/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/28/2009
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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