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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302-20

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CYBERONICS, INC. LEAD MODEL 302-20 Back to Search Results
Model Number 302-20
Event Date 07/29/2014
Event Type  Malfunction  
Event Description

Clinic notes were received indicating that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high impedance (dc dc ¿ 7). X-rays were not taken. The patient was referred for surgery but no known surgical interventions have occurred to date. The notes showed normal device diagnostic results through (b)(6) 2013.

 
Event Description

It was reported that the patient underwent generator and lead replacement surgery. The generator was reported to be replaced prophylactically. It was reported that pre-operative system diagnostic resulted in high impedance (dc dc code - 7). Pre-operative device settings showed that the device had not been programmed off. The generator was replaced and device diagnostics again resulted in high impedance (>10,000 ohms). The lead was then replaced. Device diagnostics with the new vns system were within normal limits. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

(b)(4).

 
Event Description

Analysis of the generator was completed on 10/14/2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on 10/29/2014. A break was identified in the positive coil. Scanning electron microscopy images suggest pitting or electro-etching conditions at the suspected broken end of the positive coil of the second portion of the returned lead. Due to metal dissolution the fracture mechanism cannot be determined. Scanning electron microscopy images of the suspected positive coil (mate end to the second portion) located at the 3rd portion of the returned lead indicate a stress-induced fracture (fatigue) in at least three strands of the quadfilar coil. Also, the coils wires have mechanical distortions (smoothed surfaces) in the vicinity of the break. 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 portions.

 
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Brand NameLEAD MODEL 302-20
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 Key4085398
Report Number1644487-2014-02330
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 08/15/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/12/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2008
Device MODEL Number302-20
Device LOT Number1169
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/18/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/14/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/11/2005
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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