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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 04/02/2012
Event Type  Malfunction  
Event Description

Additional information was received on (b)(6) 2012, when product analysis was completed on the explanted generator. The generator was found to be at end of service and was determined to be the result of normal battery depletion. The depletion was an expected event as determined by battery life calculation and battery voltage measurement. The module performed according to functional specifications and there was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Product analysis on the lead was completed on (b)(6) 2012. The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis a lead break was observed. Scanning electron microscopy was performed and identified the areas as having evidence of being worn to the point of fracture with flat spots on the coil surface, no pitting and residual material. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. The abraded opening found on the connector ring inner silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the inner silicone tubing. There was no obvious path found for the fluid ingress observed inside the connector pin inner silicone tubing. With the exception of the observed discontinuity, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies 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 portion were performed, during the visual analysis, and no other discontinuities were identified.

 
Event Description

On (b)(6) 2012, a vns implanting surgeon's nurse stated that the vns patient had their leads replaced on (b)(6) 2012, due to the surgeon observing electrode damage when replacing the generator due to end of service. When the new generator had been implanted, diagnostics performed showed high impedance and the electrodes appeared to be damaged; therefore the leads were replaced. The explanted lead and generator were returned to the manufacturer for product analysis on (b)(6) 2012, that has not yet been completed. The surgeon later reported that the generator had been at end of service so the lead impedance could not be tested prior to surgery. Surgery was the first time the high impedance we observed. The surgeon was unsure if x-rays were taken prior to surgery or if patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. A battery life calculation was performed with the patient's programming history which showed negative years until the elective replacement indicator is flagged as yes.

 
Manufacturer Narrative

Analysis of programming history. 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.

 
Manufacturer Narrative

(b)(4).

 
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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 Key2572452
Report Number1644487-2012-01211
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/19/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/14/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/30/2008
Device MODEL Number302-20
Device LOT Number1239
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/30/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/21/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/30/2005
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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