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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 300

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CYBERONICS, INC. LEAD MODEL 300 Back to Search Results
Model Number 300-30
Event Date 01/01/2013
Event Type  Malfunction  
Event Description

The generator and lead were returned on (b)(6) 2013 and are pending product analysis.

 
Event Description

It was reported that during generator replacement for eos = yes system diagnostics were run with the new generator and existing lead which resulted in high impedance reading. It was reported that the generator was completely dead in pre-op therefore diagnostics could not be run before the new generator was implanted. The surgeon then replaced the lead. A new generator and lead were implanted. It was reported that the explanted devices will not be returned to manufacturer for analysis per hospital policy. The surgeon reported that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The neurologist indicated that the patient had scar tissue on the vagus nerve and that there was partial erosion into a small area of the medial aspect of the left internal jugular vein which is believed to have caused or contributed to the high impedance.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death.

 
Manufacturer Narrative

Only a portion of the lead was returned for analysis, which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

 
Event Description

The lead assembly was returned in one portion. A portion of the lead assembly (body) including the electrodes and tie downs was not returned. Setscrew marks were observed on the marked and unmarked connector pins. The marks provide evidence of a proper mechanical contact between conductive surfaces of both the generator and connector pin, thereby ensuring a good electrical connection to the lead. White deposits were observed on the outer silicone tubing. The generator was returned as it was not implanted in the patient. Visual examination showed no visual anomalies. The septa were not cored. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 995 volts as measured during completion of the final electrical test, shows a non-ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator.

 
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Brand NameLEAD MODEL 300
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 Key3325040
Report Number1644487-2013-02604
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/08/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/04/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2002
Device MODEL Number300-30
Device LOT Number1041
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/12/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/16/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/16/2000
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: 09/04/2013 Patient Sequence Number: 1
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