• 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 304

  • 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 304 Back to Search Results
Model Number 304-20
Event Date 11/06/2012
Event Type  Malfunction  
Event Description

It was initially reported that the patient had high lead impedance (>7000 ohms, neos - no). The high impedance was seen when the physician interrogated the patient's device and a high impedance warning message was received. The patient had been doing some heavy lifting while moving apartments. Following this he began experiencing some pain on the left side of his neck, head and shoulder. The pain was described as constant throbbing which was not relieved with tylenol. The patient can into the physician office for an appointment related to his and the high impedance was seen. The patient had their setting turned down and them off and the high impedance remained. The physician chose to turn the patient back on as vns has helps with seizures. The patient was referred for x-rays. X-rays will not be provided to the manufacturer for review. The physician reviewed the x-rays and there were no lead breaks visualized. The patient also had a more intense seizure about the same time of the move. The physician increased his dose of keppra and asked him to get his level checked. It was determined that his keppra level was low. He did not have any more seizure at the time of the report to the manufacturer. It is unknown by the physician if the more intense seizure was related to vns or the high impedance. The patient had a generator and lead replacement. Good faith attempts for product return have been unsuccessful to date.

 
Event Description

Additional information was received that the generator and lead were returned to the manufacturer for evaluation. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications as defined in (b)(4). The battery, 3. 012 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test, shows a non-ifi condition. The data in the diagaccumconsumed memory locations revealed that 11. 119% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
Manufacturer Narrative

Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, 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 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 Key2911574
Report Number1644487-2013-00130
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/12/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2014
Device MODEL Number304-20
Device LOT Number201584
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/03/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/03/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/29/2010
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: 01/11/2013 Patient Sequence Number: 1
-
-