MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

Model Number 304-20

Device Problems Crack (1135); Moisture or Humidity Problem (2986)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015 it was reported that the patient's prophylactic battery change turned into the full revision because fluid was found inside the lead casing upon inspection.When inspecting the lead prior to new battery replacement, the surgeon noticed that the covering on the lead had cracks in it and there was fluid inside of the lead casing.He made the decision that the proper thing would be to do a full system replacement for this patient.When he went into the neck, he discovered that there was only one tie down used for the initial placement, and thinks that this may have been a cause for the cracking of the lead covering due to extra torque on the lead.It was reported that the fluid was not noticed in the inner tubing.The pre-op and post-op diagnostics were reported to be ok.Pre-op diagnostics: communication: ok/ output status: ok / current delivered: 2.75 ma/ lead impedance: ok/ impedance value: 2586/ ifi: no.The dhr for the lead was reviewed; device met all specs prior to distribution.The explanted lead was returned for product analysis on (b)(4) 2015.Product analysis is still underway and has not yet been completed.

Event Description

Product analysis was completed on the leads on (b)(6) 2015.During the visual analysis of the returned 152mm portion the end of the connector ring quadfilar coil appeared to be broken approximately 105mm from the end of the connector boot.Scanning electron microscopy was performed and identified the area as having extensive pitting (with residual material) which prevented identification of the coil termination, but the end appearance of the quadfilar coil strands implied the coil had been cut.Pitting was observed on the coil surface.The generator was ¿on¿, when received (post-explant).Therefore, the observed pitting is most likely associated with a coil that remained attached to a generator whose output remained ¿on¿, until it was received into product analysis for evaluation.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 found 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.With the exception of the abraded openings observed on the outer silicone tubing and the pitting observed on the connector ring quadfilar coil due to continued stimulation, post explant, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious product 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 discontinuities were identified.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• 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 Key: 5107837
• MDR Text Key: 27075838
• Report Number: 1644487-2015-05913
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/06/2013
• Device Model Number: 304-20
• Device Lot Number: 201288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 28 YR