• 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 303

  • 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 303 Back to Search Results
Model Number 303-20
Event Date 10/01/2013
Event Type  Malfunction  
Event Description

On (b)(6) 2013, it was reported that the patient's vns leads were replaced due to high lead impedance. The high lead impedance was first observed on (b)(6) 2013. The patient came in with a generator that was dead and could not be interrogated pre-op. The device was not programmed off after the high impedance was observed. It was unknown if patient manipulation or trauma occurred that may have caused or contributed to the event. The old generator was placed over the scapula and the patient would complain would bang against her clavicle. A lead fracture was observed during surgery on (b)(6) 2013. When the new generator was connected to the old lead, a persistent high impedance was present on multiple tests. X-rays were not taken prior to surgery. The explanted lead was returned to the manufacturer and product analysis was performed. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis broken coil strands were observed on the (+) connector ring tri-filar coil approximately 260mm-261mm from the connector boot. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting. During the visual analysis the (-) connector pin tri-filar coil appeared to be broken approximately 286mm from the connector boot. Scanning electron microscopy was performed and identified the area on one of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting. The area on the remaining broken coil strands was identified as having extensive pitting which prevented identification of the coil fracture type. During the visual analysis the (+) connector ring tri-filar coil appeared to be broken approximately 329mm from the connector boot. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (torsional appearance) with mechanical damage and no pitting. 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. The abraded opening, tool / slice marks found on the bilumen 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 found inside the bilumen tubing. With the exception of the observed discontinuities, 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 portion were performed, during the visual analysis, and no other discontinuities were identified. Note that a break of a few strands would still allow current flow through that portion of the lead. This observation is supported by results of electrical measurements which verified continuity between the ends of this lead section. Note that since the electrodes were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Review of the lead device history records confirmed all quality tests were passed prior to distribution. Device was reworked to extend expiration date.

 
Manufacturer Narrative

Device failure occurred, 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 303
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
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 Key3521241
Report Number1644487-2013-03795
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/18/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/16/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2013
Device MODEL Number303-20
Device LOT Number2440
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/18/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/18/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/18/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-