MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problems Break (1069); Unexpected Therapeutic Results (1631); Low impedance (2285)

Patient Problems Seizures (2063); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 05/01/2014

Event Type  malfunction  

Event Description

The slice mark and 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.The abraded openings found on the inner silicone tubes 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 inner silicone tubes.

Event Description

Analysis of the returned lead portion was completed and confirmed lead discontinuity.Abraded openings of both inner tubing sections were found.There is evidence to suggest that both coils were in contact with each other, leading to a potential short circuit condition.

Manufacturer Narrative

Device failure occurred, but did not cause or contribute to death.

Manufacturer Narrative

Describe event or problem, corrected data: the supplemental report #1 inadvertently did not report this data.

Manufacturer Narrative

Device manufacture date, corrected data: the supplemental report #2 inadvertently did not report this data.

Event Description

It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed low impedance.The patient¿s device settings were increased but the patient did not exhibit any signs of receiving therapy.The physician¿s handheld device showed that low impedance was first observed at generator replacement surgery on (b)(6) 2014.The device impedance value fluctuated between < 600 ohms and 869 ohms since the replacement procedure.It was noted that the patient¿s previous generator showed low impedance (dc dc ¿ 0) prior to replacement.The physician stated that the patient had been experiencing an increase in seizures since (b)(6) 2014.An implant card was received indicating that the patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity.The surgeon observed a lead break during explant.The explanted generator and lead were returned to the manufacturer for analysis.There were no performance or any other type of adverse conditions found with the pulse generator.Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.Analysis of the returned lead portion is currently underway.

Manufacturer Narrative

Device failure is suspected, but did not cause or contribute to a death or serious injury.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• 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 Key: 4195520
• MDR Text Key: 5227477
• Report Number: 1644487-2014-02793
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2001
• Device Model Number: 300-20
• Device Lot Number: 22821C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/1999
• 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 Outcome(s): Required Intervention
• Patient Age: 18 YR