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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
Device Problems Break; Crack; Battery Problem
Event Date 01/16/2015
Event Type  Malfunction  
Event Description

On (b)(6) 2015 it was reported that the patient¿s lead seems to have ¿cracked/broken¿. Per the physician, an x-ray was taken which showed a disruption in one of the leads about 1 cm superior to the generator. It was also reported that the patient¿s battery is at end of life as it has been implanted almost 12 years. The patient was referred for surgery. Although surgery is likely, it has not occurred to date. It was stated that there was no report of high impedance prior to the consult. The patient underwent a full revision surgery on (b)(6) 2015. The explanted products could not be returned for product analysis as the hospital discards them. Good faith attempts for further information from the physician have been unsuccessful.

 
Event Description

On (b)(6) 2015 the physician reported that high impedance had been observed on a system diagnostics test. The high impedance was first seen on (b)(6) 2015. It was stated that there was no known direct trauma to the device that could have caused or contributed to the high impedance.

 
Manufacturer Narrative

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

 
Event Description

On (b)(6) 2015 it was reported that the explanted lead and generator would be returned for product analysis. They have not been received to date.

 
Event Description

On 10/13/2015 the generator and lead were received for product analysis. Product analysis was completed on the generator on 10/27/2015. Based on the electrical test results, the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an end-of-service condition. A battery life estimation resulted in 0. 50 years remaining before the eri flag would be set. Therefore, the electrical performance of the generator, as measured in the product analysis lab, will be used to conclude that no anomalies exist and the end-of-service condition is an expected event. The pulse generator module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.

 
Event Description

Product analysis was completed on the leads on (b)(4) 2015. The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 199mm portion the end of the connector pin quadfilar coil appeared to be broken approximately 192mm from the end of the cut outer silicone tubing. Scanning electron microscopy was performed and identified the area on one of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on a second broken coil strand was identified as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. The area on a third broken coil strand was identified as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type and no pitting. The area on the fourth broken coil strand was identified as having evidence of being worn to the point of fracture and no pitting. Flat spots and pitting was observed on the coil surface. During the visual analysis of the returned 7mm portion the end of the quadfilar coil appeared to be broken. Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with fine pitting. Flat spots and pitting were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening and abraded open / cut areas found on the outer silicone tubing and the cut ends that were made during the explant process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. For the observed 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 abraded open / cut found on one of the inner silicone tubes. 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.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key4570324
Report Number1644487-2015-04038
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/09/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/04/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2005
Device MODEL Number302-20
Device LOT Number009273
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/13/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/16/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/30/2003
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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