• 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 300

  • 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 300 Back to Search Results
Model Number 300-30
Event Date 12/02/2011
Event Type  Malfunction  
Event Description

Clinic notes dated (b)(6) 2011, were received from case management which revealed that the patient had experienced chest pain for the past (b)(6) months, which radiated down her axilla and arm. The patient has had catamenial seizures affecting her right arm since age fifteen. She has had spells of right arm stiffening two years prior to her first generalized tonic-clonic seizure at age (b)(6). It was reported that vns has "reduced her seizures from daily to only associated with menses. " the patient was seen on (b)(6) 2011, on an urgent basis due to a new onset of headaches that required hospitalization, as well as seizures. The patient's seizures have been variable over the years from five seizures per day, to as many as twenty per day (30% during wakefulness and 70% waking her from her sleep), especially during ovulation and onset of menses. However prior to vns, she had them outside her menses as well. The patient experiences multiple focal seizures around her menses. The patient's chest pain is described as sharp affecting the lateral and posterior region of her left chest. However, palpation does not recreate pain, rather, the pain is created by stretching. The patient takes hydrocodone and ibuprofen for the left chest pain. The patient was concerned that vns may be causing the pain. Further more, the patient called the physician on (b)(6) 2011, as documented in the clinic notes because she was having chest pain and went to a cardiologist who alleged that she has a "broken wire" in her vns. The patient reported that the cardiologist felt around it and stated that he "felt a pulse where it was broken. " the patient reported that the pain was so bad, when she got home that she took a percocet, but the pain still persisted around her heart area, left axilla, and down her left arm to her hand. The patient wanted to know what to do because the pain was progressing. The patient was referred for a stat chest x-ray to check the leads. However, no lead breaks were noticed by the physician during a review of the x-rays. The patient was prescribed percocet. The patient was also referred for a consult with a surgeon for a new generator or vns adjustment. The x-rays were not sent to the manufacturer for analysis. The patient had generator replacement surgery on (b)(6) 2011. Attempts for additional information from the patient's neurologist's office have been unsuccessful thus far. The reason for generator replacement is not known at this time. The diagnostics performed on (b)(6) 2011, did not indicate that there was a device malfunction. A batter life calculation was performed with the history available in the in-house programming database, and the results were approximately 3. 91 years until eri=yes.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 300
Manufacturer (Section D)
CYBERONICS INC
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key2387860
Report Number1644487-2011-03140
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/05/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2003
Device MODEL Number300-30
Device LOT Number4308
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/05/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2001
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: 12/20/2011 Patient Sequence Number: 1
-
-