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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 302-30
Event Date 06/18/2012
Event Type  Malfunction  
Event Description

An implant card from this vns patient's implant surgery on (b)(6) 2012 was received on (b)(6)2012 indicating lead impedance was seen after the new generator was implanted; therefore, the lead was also replaced. Operative notes were received on (b)(6) 2012. The generator was explanted and a new model 103 generator was attached to the existing leads. Interrogation showed lead impedance to be high. Repeat interrogation showed the same thing. The generator was disconnected and then reconnected and still showed high impedance. During dissection for lead replacement, a large amount of fibrous adhesions were noted where the lead was attached to the nerve. The uppermost portion of the old lead was dissected away from the nerve allowing for a longer exposed nerve for attachment. Interrogation was performed and lead impedance was okay. A strain loop was created with two pledgets and then another strain loop was created. The old lead was bluntly removed. The generator was disconnected, the lead was tunneled to the generator site, the generator was connected to the lead, and interrogation showed normal lead impedance and full battery life. The generator was placed in the pocket, and another interrogation showed normal lead impedance. Notes from the patient's appointment on (b)(6) 2012 were also received in (b)(6) 2012. The notes indicated that the patient experienced a hoarse voice for a little while; however, it appeared to be better on this date. The patient's incisions were reported to be healing well without evidence of infection. No hoarseness was detected. It was noted that injury or irritation of the vagus nerve or recurrent laryngeal nerve was a concern; however, it was believed that if the nerve was actually damaged, the effect on voice would be more dramatic. It was suspected that some vocal cord irritation form endotracheal intubation was the culprit, hence the improvement with time. If the issue was of concern in a few weeks, the patient would be referred to an ent for visualization of the cords. Attempts for product return and additional information have been unsuccessful.

 
Event Description

Clinic notes dated (b)(6) 2011 and (b)(6) 2012, were reviewed on (b)(6) 2012 and indicated that the device was "working well. " on (b)(6) 2012, it was reported that the patient's explanted devices had been discarded and were unavailable for product return. Additional information was received on (b)(6) 2012, indicating that high impedance was not seen until the generator was replaced. Pre-operative diagnostics were not performed. A battery life calculation on (b)(6) 2012, indicated negative results at the time of revision surgery.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Analysis of programming history.

 
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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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2669499
Report Number1644487-2012-01885
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/27/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/25/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2006
Device MODEL Number302-30
Device LOT Number011040
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/25/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/28/2004
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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