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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
Device Problem Migration or Expulsion of Device
Event Date 01/01/2014
Event Type  Injury  
Event Description

It was reported that the patient's generator has migrated and is causing constant pain at the chest site. Device diagnostics were within normal limits. The patient was referred for x-rays. The physician believes that the migration is a result of weight change and growth since implant. It was reported that surgery will be required to reposition the device. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Event Description

It was reported by the physician that the patient has had chest pain, in the form of an intermittent shocking pain, for over a year. It was reported this pain radiates to the neck and epigastric regions. It was reported that deactivation of the vns system does not help. The patient's x-rays appeared normal and system diagnostics all appeared normal. The patient has been referred for replacement. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

 
Event Description

It was reported that the team of physicians elected to proceed with a generator replacement in an attempt to resolve the complaint of intermittent radiating pain. Surgery was performed on (b)(6) 2015. A diagnostic test was performed which showed the device was working as intended prior to explant. During the surgery, the physician noticed inflammation surrounding the generator site that he thought to be caused by the original placement of the device. Upon closing the patient, the surgeon witnessed a small break in the lead about an inch away from the lead pin. A full revision was performed, having the lead and generator both replaced. A diagnostic test was run with the newly implanted device which still showed normal impedance levels. The explanted lead and generator were sent to the pathology department of the hospital. It was also found by the surgeon during surgery that the explanted lead did not appear to be attached to the correct nerve. Attempts for additional relevant information have been unsuccessful to date.

 
Manufacturer Narrative

Evaluation, corrected data: this information was inadvertently left off of supplemental #02 mfr. Report.

 
Event Description

The surgeon later described the inflammation found during surgery. He stated the lead insulation was torn with exposed wires at the generator site. The surgeon also stated the patient's pain has resolved since the vns revision surgery. No additional relevant information was received.

 
Manufacturer Narrative

Brand name; corrected data: this information was inadvertently not updated on supplemental #02 mfr. Report. Type of device; corrected data: this information was inadvertently not updated on supplemental #02 mfr. Report. Model#, serial #, lot#, exp. Date; corrected data: this information was inadvertently not updated on supplemental #02 mfr. Report. Device manufacture date; corrected data: this information was inadvertently not updated on supplemental #02 mfr. Report.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key4341541
Report Number1644487-2014-03394
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/01/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2013
Device MODEL Number302-30
Device LOT Number201108
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/29/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/03/2009
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: 12/18/2014 Patient Sequence Number: 1
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