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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-30
Event Date 12/10/2012
Event Type  Malfunction  
Event Description

On (b)(6) 2013 it was reported that the patient's lead is broken and was referred for revision surgery. Because the patient has shunted hydrocephalus and no recent imaging, it was stated that prior to surgery a brain mri would be performed to make sure the patient's ventricles aren't enlarged. Clinic notes were received dated (b)(6) 2013 revealed that the week prior, the patient reportedly had 30 "small" seizures on the school bus. The patient normally has about 2 generalized tonic-clonic seizures per month and 1-2 smaller tonic-clonic seizures that affect upper extremities only. The patient's grandmother noticed that the patient has recently started looking upward and the left with left eye deviation and left arm flexion during the smaller seizures. The physician noted that there is no significant change on seizure amount as per family members. High impedance was noted that day during interrogation and "a broken wire was detected". The patient's settings were noted to be output=1. 75ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=0. 8min/magnet output=2ma/magnet on time=60sec/magnet pulse width=500usec. Clinic notes dated (b)(6) 2012 indicate that for the last two weeks, the patient is presenting with sporadic jerking movements in the right shoulder during the night and the patient's guardian recounts a different type of seizure involving a shaking of the upper extremity that lasts one to two seconds and results in postictal dizziness. The patient underwent a full revision surgery on (b)(6) 2013. The hospital reported that the lead would not be returned to the manufacturer for product analysis. Attempts for the return of the explanted generator are underway but it has not been returned to the manufacturer to date. Good faith attempts for further information from the physician have been unsuccessful. The manufacturing records for the lead were reviewed and device met all specifications prior to distribution.

 
Manufacturer Narrative

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

 
Event Description

On (b)(6) 2013 it was reported that per the physician's notes, the patient's electrodes and generator were removed but the surgeon felt that there was not enough space to reimplant new electrodes due to scar tissue and therefore did not reimplant the patient. It was also reported that the explanted generator would be returned to the manufacturer for product analysis. The explanted generator was returned to the manufacturer for product analysis on (b)(4) 2013. Product analysis is still underway and has not yet been completed.

 
Event Description

Product analysis on the explanted generator was completed on (b)(6) 2013. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The generator¿s internal memory showed that the impedance value increased from 1346 ohms to 10,000 ohms on (b)(6) 2012.

 
Manufacturer Narrative

Additional information was received which changes the event date from what was originally reported.

 
Event Description

Good faith attempts for the return of the explanted products were unsuccessful.

 
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Brand NameLEAD MODEL 304
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 Key2985124
Report Number1644487-2013-00559
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/05/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/01/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2014
Device MODEL Number304-30
Device LOT Number201406
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received04/29/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/07/2010
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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