• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-30
Event Date 05/24/2011
Event Type  Malfunction  
Event Description

It was reported by a neurologist that a vns pt had high lead impedance and his seizure pattern had changed (increased duration and intensity). Prior to vns, the pt had seizures which lasted about 45 minutes but after the vns implant, the seizure duration reduced to only seconds. The frequency of seizures however has not changed. Recently, pt started having seizures which lasted 1. 5 minutes indicating a change in his seizure pattern. It was also noticed that pt had high lead impedance. There was no known trauma or contributory factor which may have led to pt's high impedance. Pt was referred for x-ray but manufacturer hasn't received the images. Pt will likely have a full revision surgery.

 
Event Description

The patient went for revision surgery on (b)(6) 2012, however the revision was not completed. Pre-op interrogation indicated that the output and magnet currents were both set to 0. 0 ma. Pre-op system diagnostics test on the generator indicated high impedance. X-rays were reviewed by the surgeons and they stated they did not see any obvious discontinuity in the lead. The surgeons then proceeded with the neck incision and planned removal of the old lead. Upon opening the neck incision, the surgeons indicated that there was an obvious break in the lead immediately on top of the sternocleidomastoid muscle. The surgeons did not know what may have caused the break in this location but suggested it may have been due to the neck contractures of the patient. Heavy scarring was identified in the neck and in the process of further dissecting the lead wire for removal, the surgeon encountered a bleeding issue and decided they did not want to proceed any further. The surgeon's also noted that there was previous damage to the left vagus nerve. At the time of the surgery, a portion of the lead was removed however the generator was left in. Both surgeons stated they would speak with the patient's family about further options regarding re-implanting the patient.

 
Event Description

Additional information was received indicating that the nerve damage was likely due to multiple previous vns implants on the left side nerve. The portion of the lead that was explanted was discarded following surgery. Per the patient's family, they are not considering re-implant at this time as the patient's seizures have been stable.

 
Event Description

Additional information was received on (b)(4) 2011, indicating that the patient's surgeon was inquiring about right sided re-implants if necessary. It was indicated that the surgeon was concerned about the effects or continued re-implants on the left nerve as the patient has already had two vns implants on the left side. Additional information was received from the neurologist's office indicating that x-rays were ordered, however they were uncertain if they were performed as they did not receive a copy. It was also indicated that the high impedance was first observed on (b)(4) 2011, with a dc/dc code of 7. The neurologist's office believed that the patient may not have been receiving intended therapy. No other information was provided by the neurologist. Revision is likely but has yet to occur to date.

 
Manufacturer Narrative

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

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2255846
Report Number1644487-2011-01950
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 07/25/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/22/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2008
Device MODEL Number302-30
Device LOT Number1239
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received06/06/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2005
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: 08/22/2011 Patient Sequence Number: 1
-
-