• 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 300-20
Event Date 08/30/2012
Event Type  Malfunction  
Event Description

On (b)(6) 2012, it was reported that a vns patient had a generalized tonic-clonic seizure the earlier day (date unknown). After the seizure, the patient experienced painful stimulation in her chest. The patient's diagnostics were output status: limit, impedance: high ((b)(4);10000 ohms), eos = no. The last known diagnostics, current settings, device disablement after the event, and product information were unknown. X-rays were going to be taken and would be sent into the manufacturer for review. The patient was being referred for a full revision. On (b)(6) 2012, the patient's nurse indicated that the patient's chest and neck x-rays were available and would be sent into the manufacturer for review. The nurse stated that x-rays were taken because the patient was seen the previous day, and upon running diagnostics, high impedance (b)(4);10,000 ohms) was observed. The nurse also indicated that the patient has had very few seizures since being implanted with vns; however, the patient had a generalized tonic-clonic seizure the previous week. For the past month, the patient experienced discomfort in her chest with stimulation. (this was not a shock-like sensation. ) the nurse stated that high impedance was first seen on (b)(6) 2012. It was stated that the device was not disabled. The patient was still experiencing her normal voice alteration; therefore, the device was not programmed off as it appeared that the patient was still receiving stimulation. When asked about manipulation or trauma, the nurse stated that when the patient first called regarding the discomfort, she indicated that she was dizzy. The nurse was pretty sure, but could not confirm, that the patient had fallen at that time, which could explain the dizziness and the painful stimulation. Additional information was received with the patient's x-rays. On (b)(6) 2012, the patient had a partial complex seizure at 14:10 and had a grand mal seizure at 15:10. The patient felt pretty beat up: the patient bruised up her shoulder and back. The patient was evaluated in urgent care and was told that there were no fractures, only bruise. The patient denied any missed medication and no acute illnesses. On (b)(6) 2012, the patient reported dizziness and her medication was adjusted. On (b)(6) 2012, the patient reported that she had missed medications. Since (b)(6) 2012, the patient did not report dizziness and these were the first seizures since the appointment. The patient reported a "different" feeling regarding the generator. It was not a shock, but just different. The patient had a number of seizures since her last visit. The device was stimulation her voice but she felt a weight in her chest with stimulation. The seizures were possibly secondary to an automobile accident. The patient had significant ecchymosis and pain in the left upper arm and should from the fall on her should with the seizures. It was assessed that the patient had the gtc possibly secondary to a fractured lead on the vns. The x-rays were assessed and it was written that the vns wire appears to have a break or crack based on high impedance. Vns replacement including wires was likely. The device was interrogated and diagnostics were run. X-ray images were reviewed by the manufacturer. The generator was visible and appeared to be normally placed. The connector pins appeared to be fully inserted inside the connector blocks. The feedthru wires also appeared intact. The lead was also visible. Lead was present behind the generator. There were no suspect fractures, discontinuities, or sharp angles visible. The lead wires appeared intact at the connector pins. The patient underwent total revision on (b)(6) 2012. The explanted generator and lead were received on (b)(6) 2012 and are currently undergoing product analysis. The returned product form indicated that the lead was explanted due erosion of the lead and parasthesia in the chest.

 
Event Description

An analysis was performed on the returned lead portion. Note that a portion of the lead assembly (body) including the electrodes was 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 pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions 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 portion of the device which may have contributed to the stated complaints. Product analysis on the generator showed that the high impedance noted in the lead section was not duplicated in product analysis. 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.

 
Event Description

Additional programming history was reviewed on (b)(6) 2012. High impedance was first seen on (b)(6) 2012. Impedance values and output status varied with diagnostics.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device x-rays reviewed by manufacturer; no gross lead discontinuities visualized.

 
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.

 
Manufacturer Narrative

Review of programming history.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 300
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 Key2769777
Report Number1644487-2012-02419
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/05/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/03/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/04/1999
Device MODEL Number300-20
Device LOT Number13389C
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/28/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/30/2012
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/27/1998
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-