• 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 12/01/2014
Event Type  Malfunction  
Event Description

It was reported that the vns patient¿s generator had migrated to the left armpit which was causing discomfort and pain. Clinic notes were received indicating that the physician observed the generator migration during an office visit on (b)(6) 2014. Diagnostic results from the office visit showed normal device function at that time. Follow-up revealed that the patient returned to the office on 04/06/2015 due painful stimulation that began approximately two week before the visit. The patient¿s device was tested and diagnostic results revealed high impedance. The patient¿s device was subsequently disabled and the pain subsided. The patient continued to have discomfort and stated that he could feel the device poking him under his skin. The patient was referred for surgery but no known surgical interventions have occurred to date.

 
Event Description

The explanted lead and generator were received, and 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.

 
Event Description

Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanted devices have not been returned to date.

 
Manufacturer Narrative

Device failure occurred, but did not cause or contributed to a death or serious injury.

 
Event Description

Analysis of the generator was completed on (b)(4) 2015. Electrical test results showed that the pulse generator performed according to functional. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the lead was completed on (b)(4) 2015. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 385mm portion quadfilar coil 1 appeared to be broken approximately 12mm from the electrode bifurcation. During the cleaning process a coil strand became detached from the electrode (mating) end of the quadfilar coil 1 coil break. Scanning electron microscopy was performed on the connector end of the quadfilar coil 1 coil break (found at 12mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type and no pitting. The fourth broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the electrode (mating) end of the quadfilar coil 1 coil break (found at 12mm) and identified the area on three of the broken coil strands as being mechanically damaged with pitting which prevented identification of the coil fracture type. Evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture was observed on one of these broken coil strands. The fourth broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and 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 which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. 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. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the 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.

 
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 Key4669616
Report Number1644487-2015-04407
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/18/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2012
Device MODEL Number302-20
Device LOT Number201059
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/15/2015
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/11/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/31/2009
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: 04/08/2015 Patient Sequence Number: 1
-
-