• 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 12/23/2013
Event Type  Malfunction  
Event Description

Diagnostics performed during the patient's vns generator replacement surgery (due to end of service) found high impedance. Diagnostics could not be performed prior to the surgery, as the vns battery was depleted. After replacement with the new generator, diagnostics performed showed an impedance value of greater than 10,000 ohms. The lead pin was re-inserted into the generator multiple times; however, this did not resolve the high impedance. The lead was replaced and final diagnostics showed normal impedance at a value of 2,315 ohms. Attempts were made for additional information; however, they were unsuccessful. No other information was provided.

 
Event Description

It was reported that the generator and lead were ready to be returned for analysis. The devices were returned to manufacturer on 04/11/2014. Analysis is underway, but has not been completed to date.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death. Adverse event and/or product problem, corrected data: the initial manufacturer report inadvertently did not include that the report was also an adverse event. Outcomes attributed to adverse event, corrected data: the initial manufacturer report inadvertently did not include the outcomes attributed to the adverse event. Relevant tests/laboratory data, corrected data: the initial manufacturer report inadvertently did not include information regarding the patient¿s increase in seizures and depression.

 
Event Description

It was previously reported that the vns patient was experiencing an increase in seizures and an increase in depression. The patient's device had reportedly been at end of service for some time. Analysis of the returned generator and lead was completed. The end of service condition was determined to be the result of normal battery depletion. The depletion was an expected event as determined by blc and battery voltage measurement. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. During the visual analysis of the returned 240mm lead portion, quadfilar coil 1 appeared to be broken approximately 2mm from the end of the abraded open / cut / outer silicone tubing. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type with pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity. The abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process and the abraded opening observed on one of the inner silicone tubes. With the exception of the observed discontinuity, the condition of the returned lead portions 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 portions were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the high impedance. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 302
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3582656
Report Number1644487-2014-00273
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 12/23/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/17/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2006
Device MODEL Number302-20
Device LOT Number010939
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/11/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/20/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/15/2004
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: 01/17/2014 Patient Sequence Number: 1
-
-