• 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 302-20
Event Date 06/25/2012
Event Type  Malfunction  
Event Description

It was reported that a vns patient had high lead impedance with a dcdc 7. The patient is having seizures which they think is from their vns not working. No x-rays have been ordered. The patient did not have any fall or injury preceding the event. The patient is referred for surgery (b)(6) 2012.

 
Manufacturer Narrative

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

 
Event Description

The patient had surgery (b)(6) 2012. Our consultant attended the surgery reported that when the surgeon exposed the carotid sheath, he stated there was not enough room remaining on the vagus nerve to place another lead. For this reason, the lead was cut and the electrodes remain on the nerve. No new system was implanted. The explanted portions of the lead were not returned for analysis. Their explanted generator was returned for analysis. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

 
Manufacturer Narrative

Device malfunction occurred, but did not cause or contribute to a death.

 
Event Description

An analysis was performed on the returned lead portion. Note that the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the connector pin quadfilar coil appeared to be broken approximately 240mm (connector end) and 243mm (electrode mating end) from the end of the connector boot in the area of observed abraded openings. Visual analysis was performed and identified the areas as having extensive pitting which prevented identification of the coil fracture type and mechanical damage. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. What appeared to be remnants of dried body fluids and white deposits were observed inside the outer and connector pin inner silicone tubing, throughout the majority of the returned portion. The abraded openings found on the outer and connector pin inner silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids / white deposits found inside the outer and inner silicone tubing. With the exception of the observed discontinuity, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other 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, and no other discontinuities were identified.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 302
Type of DeviceLEAD MODEL 302
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 Key2664590
Report Number1644487-2012-01843
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/25/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/23/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/31/2008
Device MODEL Number302-20
Device LOT Number1334
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date08/23/2012
Event Location Other
Date Manufacturer Received08/23/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/12/2005
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: 07/23/2012 Patient Sequence Number: 1
-
-