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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 01/01/2013
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

Additional information was received that the high impedance was seen (b)(6) 2013 and the patient was turned off that day. The last good diagnostics was (b)(6) 2013 however results were not provided. X-ray were taken but will not be sent in to manufacturer for review. During surgery there was a lot of scar tissue that was seen and there were no lead breaks or other issue visualized. It was unknown if this was the cause of the high impedance but it was felt that it may have contributed. The cause of the fibrosis/scar tissue was unknown. Product analysis was completed on the generator and lead. Results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. The battery is 2. 889 volts (not at ifi). The data in the diagaccumconsumed memory locations revealed that 65. 153% of the battery had been consumed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Review of internal memory shows that the high impedance occurred (b)(6) 2013. During the visual analysis of the returned 390mm portion the (+) connector ring quadfilar coil appeared to be broken approximately 331mm from the end of the connector boot. Scanning electron microscopy was performed and the area was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, zirconium, sulphur and calcium. With the exception of the observed discontinuity, 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.

 
Event Description

It was reported that the patient would have a full vns revision surgery due to high lead impedance. The device was replaced due to "malfunction of vns device and high lead impedance" on (b)(6) 2013, per the hospital. Device manufacturing records were reviewed and no unresolved non conformances were found. Attempts have been made for additional information; however, they have been unsuccessful.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3357554
Report Number1644487-2013-02798
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/21/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/19/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device EXPIRATION Date09/30/2006
Device MODEL Number302-20
Device LOT Number011251
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/12/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/25/2013
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/20/2004
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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