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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 12/18/2013
Event Type  Malfunction  
Event Description

On (b)(6) 2013, it was reported that system diagnostics showed dcdc=0. Device settings were noted and there had been no change in seizures (still seizure-free); however, the patient was no longer feeling the stimulation since an unknown date. The patient¿s settings were increased, but the patient still could not feel the stimulation. Diagnostics were again performed, which showed dcdc=0 on system and dcdc=1 on normal mode. It was decided at that time that the patient would be referred for lead revision due to a suspected short circuit. Clinic notes dated (b)(6) 2013 were received. Diagnostics on this date showed unclear diagnostic results; however, it is believed that the results were within normal limits with neos: yes. Attempts will be made for additional information. No other information has been received to date. Surgery is likely, but has not occurred to date.

 
Manufacturer Narrative

Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

On (b)(6) 2014, it was reported that following an increase in settings, the patient still could not feel stimulation in the neck but could now feel stimulation in the chest. Diagnostics showed dcdc=0, but there was no ¿limit¿ output status. On (b)(6) 2014, the patient underwent surgery. A battery and lead inspection reportedly showed a lead impedance issue. The lead and generator were explanted but not replaced at this time due to significant scarring around the jugular. Additional information was received stating that surgery was performed due to short circuit condition evidenced by dcdc=0 and clinical effect of stimulation in the chest. The surgery also involved repair of the side wall of the jugular vein and a general surgeon was called in to assist. It is unknown whether the injury occurred before or during surgery. X-rays have not been taken and the patient has not been re-implanted to date. Patient manipulation or trauma is not believed to have occurred. Attempts to have the product returned for analysis were made but have been unsuccessful to date.

 
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Brand NameBIPOL LEAD 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 Key3570955
Report Number1644487-2014-00212
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/18/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/13/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/1999
Device MODEL Number300-20
Device LOT Number5533C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received03/21/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/20/1997
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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