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

Model Number 304-20

Device Problems High impedance (1291); Device Operates Differently Than Expected (2913)

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

Event Date 02/22/2016

Event Type  malfunction  

Event Description

A report was received indicating that a patient was to undergo a lead revision with possible prophylactic generator replacement due to the observation of high lead impedance (>10,000ohms).X-rays were taken but no fractures were visible on the x-rays.The pulse generator was turned off.The physician believes the patient manipulated the implanted system leading to an interrupted connection in the lead.The patient underwent full system revision due to the observed high impedance situation.At the time of lead replacement it was noted that the lead was severely twisted.The pulse generator was explanted prophylactically and replaced.The impedance with the newly implanted pulse generator and lead was normal.The explanted pulse generator and lead are expected to be returned for product analysis.

Event Description

The lead was returned for analysis in six pieces.The overall appearance of the lead is consistent with patient manipulation of the implanted device, a twiddler.The outer silicone tubing has a compress/twisted appearance along the lead bod.Three sets of setscrew marks were seen on the connector pin providing evidence that proper contact between the setscrew and the connector pin existed at least once.A break (fracture) was identified in the positive coil and appears to have pitting at the broken end.Abraded openings were identified on both the outer and inner silicone tubing in several locations including at the break location.The connector pin also showed evidence of pitting.The closest electrode to the bifurcation has creases on the electrode ribbon most likely caused during manipulation of the electrode at implant/explant.The furthest electrode to the bifurcation has creases on the electrode ribbon and partial detachment of the electrode ribbon from the silicone helix, most likely caused during manipulation of the electrode at implant/explant.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing.There were no performance or any other type of adverse conditions found with the pulse generator.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery voltage was measured to be 3.016 volts and shows an ifi=no condition.Review of the data downloaded from the pulse generator shows an indication of increased impedance from a value of 6,392 ohms to 10,777 ohms on (b)(6) 2016 indicating that the high impedance condition was present at least as early as this date.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.

• 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: 5546013
• MDR Text Key: 42547245
• Report Number: 1644487-2016-00703
• 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
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2018
• Device Model Number: 304-20
• Device Lot Number: 203077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2014
• 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: 49 YR