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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 11/21/2014
Event Type  Malfunction  
Event Description

On 12/22/2014 product analysis was completed on the generator. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 938 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis was completed on the leads on 01/05/2015 which confirmed discontinuity of both positive and negative quadfilar coils in the electrode region of the returned lead portions. A break was identified at the end of both positive and negative coils in the single returned lead portion. Scanning electron microscopy images of the positive and negative coil ends show that pitting or electro-etching conditions occurred at the break locations. Appearance of the lead coils suggests a stress-induced fracture occurred in at least one strand of the quadfilar coils. In addition, the appearance of one strand of the positive coil suggests a stress-induced fracture due to rotational forces occurred. Also, the early stages of secondary stress fractures and what appear to be stress fissures were identified in the vicinity of the break locations. Due to mechanical distortion (smoothed surfaces) and/or pitting a conclusive determination of the fracture mechanism of other strands cannot be made. The negative coil has what appears to be pitting at the area where the coil is discolored. Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
Manufacturer Narrative

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

 
Event Description

It was reported that the patient has a shocking sensation since (b)(6) 2014 and his generator was disabled due to it. X-rays were taken and the physician confirmed that the lead had come apart 3cm away from the end of the distal lead, high impedance had been observed during diagnostics. No accidents were reported to have occurred. The patient was referred for a full revision surgery. The patient underwent a full revision surgery on (b)(6) 2014. The explanted lead and generator were returned for product analysis. Product analysis is still underway and has not yet been completed.

 
Manufacturer Narrative

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

 
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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 Key4334253
Report Number1644487-2014-03339
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/24/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/16/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2014
Device MODEL Number304-20
Device LOT Number2727
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/04/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/22/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/08/2010
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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