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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 08/25/2009
Event Type  Injury  
Event Description

Initially, it was reported that the patient has experienced pain in the left jaw and teeth. The patient was evaluated by a dentist, but nothing was found wrong with the patient's mouth or teeth. The patient disabled the device with the magnet and the pain went away; however, when the magnet was removed the patient began choking and gagging. The patient reported that there appears to be muscles twitching in his neck area. The patient indicated that he is no currently followed by a treating physician and the patient was provided with vns treating physicians. It was later reported that the patient would be referred to surgeon for full vns revision surgery. Clinic notes dated (b)(6) 2014 note that the patient is having trouble with vns and the device was disabled and will likely require a full revision. No additional relevant information has been received to date. No surgical intervention has been performed to date.

 
Event Description

It was reported that the patient underwent generator replacement. The lead was not replaced. Device diagnostics prior to and during surgery were within normal limits. It was reported that the explanting facility does not returned explanted devices for analysis.

 
Event Description

It was reported that the patient was turned up that day from 1. 0ma to 1. 25ma. Everything was fine while he was at the physician¿s office but when he got home he experienced pain in his jaw again. It only lasted a little bit. The physician stated that the patient is having the same pain in the jaw with the new generator. The patient used to be set at 1. 75ma, but now when they turn the current up to 1. 25ma the patient experiences instant pain when the device turns on. He also states that after a few hours of normal operation the pain gets worse. Settings are output=1-1. 25ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=5omin. Diagnostics are ok; impedance=2213ohms. The physician stated that they would try adjusting the pulse width and decreasing the duty cycle.

 
Manufacturer Narrative

Device manufacture date; corrected data: additional information was received that changes the product from the generator to the lead.

 
Event Description

Follow-up revealed that the vns patient¿s device was disabled on (b)(6) 2014. The patient underwent surgery on (b)(6) 2015 to explant his device due to pain and to pursue an alternative treatment option. During the procedure, the surgeon noted that the electrodes were not in proper alignment and had been implanted upside-down. Additionally, a tie-down had been placed on the electrode coil on the nerve. No other tie downs were observed. The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

 
Event Description

On (b)(6) 2015 the patient reported that his vns has been turned off for about 5. 5 months because of ¿several problems¿. It was later reported that the patient has had his device for a while due to painful stimulation. The patient will be proceeding with explant of the vns device. Although surgery is likely, it has not occurred to date.

 
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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 Key3845774
Report Number1644487-2014-01399
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/06/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/03/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2010
Device MODEL Number302-20
Device LOT Number7541
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/07/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/17/2002
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/03/2014 Patient Sequence Number: 1
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