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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 08/29/2012
Event Type  Malfunction  
Event Description

On (b)(6) 2012, it was reported that the vns patient was scheduled for a prophylactic battery replacement on (b)(6) 2012; however, during surgery, the lead was determined to need replacement due to the lead being frayed and the wires exposed. The surgeon later stated that system diagnostics from surgery showed dcdc=0 and lead impedance=ok. No x-rays were taken prior to surgery. No patient manipulation or trauma occurred that is believed to have caused or contributed to the lead fraying/wires exposed. The explanted lead and generator were returned for product analysis on (b)(6) 2012. Product analysis is still underway and has not yet been completed. The reason for explant on the form received with the explanted products indicated that the housing on the leads were frayed and the wires were exposed. Clinic notes dated (b)(6) 2012 were received, which indicate that the patient's mother has not noticed the patient's voice changing at all lately with activation of the magnet. Clinic notes dated (b)(6) 2011, stated that the patient's vns was interrogated and settings left unchanged but the physician was unable to perform a lead test due to poor patient cooperation. The patient was referred for prophylactic generator replacement since the patient was reaching end of service. The patient's programming history was reviewed and all the system diagnostics tests showed results within normal limits and all showed a dcdc of 0 except for one date ((b)(6) 2005) that showed a dcdc of 2.

 
Event Description

Additional information was received on (b)(6) 2012 when product analysis was completed on the explanted generator. The generator performed according to functional specifications. Product analysis on the generator was completed on (b)(6) 2012. During the product analysis there were no anomalies found with the pulse generator. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed on the same type of white deposits found during the visual analysis of similar lead products and identified them as containing silicon, calcium, sodium and phosphorus. The abraded openings on two adjacent sections of inner tubing created a condition whereby the exposed conductive coils could come in contact with each other and creating a potential short-circuit condition. The condition of the returned lead portions is consistent with those that typically exist following an explant procedure. No other obvious anomalies, beyond the abraded openings, were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Device failure occurred, 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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2755718
Report Number1644487-2012-02418
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/24/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2005
Device MODEL Number302-20
Device LOT Number009063
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/13/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/27/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/26/2003
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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