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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 302-20
Event Date 07/15/2013
Event Type  Malfunction  
Event Description

The explanting facility discarded the explanted device; therefore, no analysis can be performed. X-rays dated (b)(6) 2013 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement; however, only a small portion of the generator is visible. The filter feed-through wires and the lead pin cannot be assessed with the images provided. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance remains unknown.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

 
Event Description

It was reported that device diagnostics resulted in high impedance. It was reported that the patient was experiencing chest pain associated with magnet stimulation. It was reported that the physician did not program the device off after observing the high impedance because the patient has good seizure control and the patient's mother did not want the device disabled. The magnet output current was reduced and the magnet mode stimulation did not cause the patient pain. X-rays were ordered and a lead revision was discussed. It was reported that the patient's family did not recall a fall, accident or manipulation that could have caused or contributed to the high impedance. It as later reported that x-rays were performed and surgery was scheduled. It was reported that the patient underwent lead replacement surgery on (b)(6) 2013. It was noted that pre-operative diagnostics resulted in high impedance (>=10,000 ohms) and that device diagnostics with the new lead and existing generator were within normal limits (1259 ohms). The lead has not been received for analysis to date.

 
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 or serious injury.

 
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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 Key3523405
Report Number1644487-2013-03809
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/18/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/17/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2010
Device MODEL Number302-20
Device LOT Number1948
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/31/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/30/2007
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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