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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 04/18/2012
Event Type  Malfunction  
Event Description

It was reported that a vns patient was seen in clinic and they had high lead impedance. In addition, the patient has has reported hoarseness since reimplant last year. The patient has been referred to a surgeon for lead revision surgery. Because of scheduling the patient will not have the surgery until (b)(6) 2012. Their output current was initially decreased but his seizures increased significantly so they have turned him back up to his previous settings and this has got his seizures back under control. Good faith attempts are underway for further information.

 
Event Description

The patient had full revision surgery and their explanted products are at the manufacturer for pending analysis completion. Their surgeon decided to prophylactically replace their generator. No further information has been attained about their reported events.

 
Manufacturer Narrative

Device malfunction occurred but did not cause or contribute to death or serious injury.

 
Event Description

An analysis was performed on the returned lead portions. During the visual analysis the green (-) electrode quadfilar coil appeared to be discolored and broken in several areas. Visual analysis was performed and identified the areas as being thin, with pitting which prevented identification of the coil fracture type and evidence of electro-etching. One of the coil break areas was identified as being mechanically damaged which prevented identification of the coil fracture type with evidence of electro-etching. During the cleaning process the green (-) electrode ribbon, spot-weld / slug and coil became detached. This most likely occurred due to the vibration of the sonicator used in the cleaning process. Visual analysis was performed on the spot-weld / slug and identified evidence of where the quadfilar coil had been mounted on the slug. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Additionally it was observed there was outer and inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process and the slice marks observed on the outer silicone tubing. With the exception of the observed discontinuities, the condition of the returned lead portions 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 portions were performed, during the visual analysis, and no other discontinuities were identified.

 
Manufacturer Narrative

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

 
Event Description

Further diagnostic history was reviewed. Unknown date of actual event.

 
Manufacturer Narrative

Date of event: corrected data to (b)(6) 2012.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD MODEL 302
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 Key2622788
Report Number1644487-2012-01555
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/05/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/20/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2009
Device MODEL Number302-20
Device LOT Number200354
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/31/2012
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date09/10/2012
Event Location Other
Date Manufacturer Received09/10/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/18/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/20/2012 Patient Sequence Number: 1
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