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

Model Number 300-20

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Seizures (2063)

Event Date 04/01/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that the vns patient was feeling of sporadic and painful stimulation.It was reported that patient seizures are well controlled and patient has been seen a huge improvement with the vns therapy.It was reported that patient underwent generator replacement for prophylactic reason (b)(6) 2015 and the adverse events persist.The explanted generator was reported as disposed of by the hospital and will not be returned to the manufacturer.Further information was received that the intense stimulation continues with the new generator.It was also reported that patient had increase in seizures; the current seizure rate is above pre-vns levels.It was reported that the medical professional suspects a problem with the lead such as current leakage which may not appear on the diagnostic test, therefore evoked potential test in various positions will be performed.It was reported that regardless of outcome evoked potential outcome, lead revision is expected.No known surgical interventions have occurred to date.

Manufacturer Narrative

Age at time of event and date of birth; corrected data: the previously submitted mdr inadvertently provided an incorrect age at time of event and date of birth.

Event Description

Further information was received from the physician, indicating that a new diagnostic test was performed and returned impedance results within normal limits with 1344 ohms.An emg-based lead test was also performed which resulted to be normal.It was reported by the physician that, despite these results, they decided to replace both the lead and the generator (since the lead is 18 year old).No known surgical intervention has occur to date.

Event Description

An implant card received by the manufacturer and the review indicates that the vns patient underwent full revision surgery on (b)(6) 2016 and that the re-implant was due to lead break.The lead impedance for the new implant was marked as ok - 1486 ohms.The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

Event Description

A return good authorization number request was received by the manufacturer to return the explanted generator model 104 serial number (b)(4) implanted with the suspect device involved in the present case.Return of the generator for analysis is expected, but it has not been received to date.

Event Description

Portion of the suspect lead was received by the manufacturer.The explanted generator was received as well.It was reported that the reason for replacement is patient experiencing stimulation more than expected: side effect of a leak of electricity.Analysis of the suspect lead was completed and the allegations were not verified within the returned lead portions.Since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions.Review of manufacturing records confirmed all tests passed for the lead prior to distribution.

Event Description

Analysis was completed on the explanted generator and reported allegation of "high impedance" was not duplicated.Review of the data downloaded from the generator shows a possible indication of increased impedance from a value of 1305 ohms, to a value of 22812 ohms, and the time of change detection was (b)(6) 2016 (generator explant on (b)(6) 2016).The vns programming history database shows the last known diagnostic test was performed on (b)(6) 2015 with an impedance value of 1357 ohms (implant (b)(6) 2015 / explant (b)(6) 2016).Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified.In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, the battery status was ifi no.The data in the "diagaccumconsumed" memory locations revealed that 16.488% of the battery had been consumed.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 5229194
• MDR Text Key: 31679966
• Report Number: 1644487-2015-06473
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/1998
• Device Model Number: 300-20
• Device Lot Number: 3058C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/1996
• 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: 39 YR