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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 04/15/2014
Event Type  Malfunction  
Event Description

Clinic notes were received indicating that the vns patient¿s device was tested and system diagnostic results showed high lead impedance (dc dc ¿ 4). Subsequent normal and system diagnostics showed lead impedance within normal limits (dc dc ¿ 3). The patient reported that she noticed a change with her device. The patient was no longer able to perceive stimulation or voice alteration two days prior to the office visit on (b)(6) 2014. The patient also reported having hypoesthesia at her neck. No medication changes or programming changes occurred that could have caused or contributed to the hypoesthesia or decreased perception of stimulation. The patient reported no trauma related to the event. The neurologist stated that the patient¿s issues were due to battery depletion despite diagnostics showed eri = no. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. The notes indicate that the patient's device could not be interrogated during an office visit on (b)(6) 2013 so no diagnostic results were performed at that time. A battery life calculation using the available programming history showed approximately 3. 68 years until eri = yes. No known interventions have occurred to date.

 
Event Description

The patient underwent revision surgery. Follow-up with the implant facility revealed that the explanted product was discarded following surgery.

 
Event Description

Additional information was received stating that the patient¿s generator was replaced on (b)(6) 2014. The patient¿s lead was not replaced at this time. The patient underwent lead replacement surgery on (b)(6) 2014. The explanted lead has not been returned to date. Attempts for additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
Manufacturer Narrative

Explant date; corrected data: additional information indicates that the suspect device was explanted on (b)(6) 2014. Evaluation codes, conclusions; corrected data: additional information indicates that the suspect device was explanted on (b)(6) 2014. It is unknown if the explanted device was explanted.

 
Event Description

The explanting facility discarded the explanted device; therefore, no analysis can be performed.

 
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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 Key3816311
Report Number1644487-2014-01283
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/21/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/16/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2009
Device MODEL Number302-20
Device LOT Number1528
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/24/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/13/2006
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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