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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 07/28/2014
Event Type  Malfunction  
Event Description

It was reported that the patient had recently undergone generator replacement on (b)(6) 2014 due to end of service. It was reported that lead impedance with the new generator and existing lead at the completion of surgery was within normal limits (5026 ohms). It was reported that post-operative diagnostics showed high impedance. The patient began experiencing an increase in seizures and was seen in the clinic at which time device diagnostics again resulted in high impedance (>10,000 ohms). Neck x-rays were performed and the patient was scheduled for lead revision. The patient underwent lead replacement. The lead is expected to be returned for analysis, but has not been received to date.

 
Manufacturer Narrative

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

 
Event Description

Additional information was received updating the suspect device information. The explanted lead has been returned to the manufacturer where analysis is currently underway.

 
Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

 
Event Description

Analysis of the lead was completed on (b)(4) 2014. Two broken strands and two partially broken strands were identified in the positive quadfilar coil resulting in a higher than normal lead resistance value. Scanning electron microscopy images of the positive coil show that a stress-induced fracture has occurred on the two broken strands. A partial stress-induced fracture and mechanical damage was identified in the other two strands at the suspected region. Also, the early stages of secondary stress-fractures and mechanical damage were identified in the vicinity of the broken strands. Based on the sem images, the broken strands and secondary coil damage, all appear to be explant related. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Also, one set of setscrew marks was seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. Also, single setscrew mark was noted at the end tip of the connector pin suggesting that the lead connector was not inserted completely at one point in time. The connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The exact point in time of when this occurred is unknown.

 
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Brand NameLEAD MODEL 304
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 Key4178626
Report Number1644487-2014-02725
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/17/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/16/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2014
Device MODEL Number304-20
Device LOT Number201620
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/17/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/19/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/21/2010
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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