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

Model Number 304-20

Device Problems Break (1069); Low Battery (2584)

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

Event Date 02/17/2016

Event Type  malfunction  

Event Description

It was reported that during a generator replacement surgery due to a low battery, a break was found in the lead and it was replaced by the surgeon.The lead and generator have been received for analysis which is underway, but has not been completed to-date.Additional relevant information has not been received to-date.

Event Description

Analysis was completed for the returned generator 03/31/2016.An end-of-service warning message was verified and found to be associated with the output being disabled by the pulse generator.Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant.During the bench interrogation with a one and one-quarter inch spacer block between the generator and the programming wand the "pulsedisabled" and end-of-service warnings were set.With the pulse generator case removed and the battery still attached to the printed circuit board, the battery measured 1.817 volts, verifying an end-of-service condition.The pulse generator performed according to functional specifications.Other than the noted event of end-of-service-pulsedisabled, there were no performance or any other type of adverse conditions found with the pulse generator.Review of the downloaded generator data revealed no anomalies.The last >25% change in impedance recorded was on (b)(6) 2010 with an initial value of 1366 ohms and a final value of 2797 ohms and was within normal limits.Analysis was completed on the returned lead portions on 03/31/2016 and the report of lead fracture was not confirmed.The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.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.What appeared to be white deposits were observed in various locations.Energy dispersion spectroscopy was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure and no 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 discontinuities were identified.There is no evidence to suggest discontinuities in the returned portions of the device.

• 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: 5505545
• MDR Text Key: 40831040
• Report Number: 1644487-2016-00573
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2013
• Device Model Number: 304-20
• Device Lot Number: 201272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2009
• 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: 8 YR