MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem High impedance (1291)

Patient Problem Seizures (2063)

Event Date 01/31/2017

Event Type  malfunction  

Event Description

It was reported that during an office visit a system diagnostic test was completed which found that the vns system could not deliver the programmed output current.A second diagnostic test was later performed during the same visit where high impedance was observed.Based on the two system diagnostic tests, there appeared to be an intermittent impedance issue.The physician did not know of any of trauma to the patient that could have contributed to the high impedance event.It was also reported that the patient had been experiencing an increase in seizure frequency and the physician believed this was related to the high impedance event.The patient was referred for a lead and generator replacement.However, no surgical interventions are known to have occurred to date.No additional relevant information has been received to date.

Event Description

It was reported by the physician that the patient's increase in seizures was below the pre-vns frequency baseline.Generator replacement for the patient took place on (b)(6) 2017 due to prophylactic reasons.Systems diagnostics were performed post-operatively and the impedance was within normal limits.

Event Description

It was reported that during the surgery the surgeon did not attempt pin reinsertion before replacing the generator.The explanted generator has not been received to date.No additional relevant information has been received to date.

Manufacturer Narrative

Brand name, corrected data: follow-up report #2 inadvertently listed wrong device brand name.Changed lead model 304 to pulse gen model 105.Type of device, name, corrected data: follow-up report #2 inadvertently listed wrong device name.Changed lead to generator.Model #, corrected data: follow-up report #2 inadvertently listed wrong model number.Changed 304-20 to 105.Serial #, corrected data: follow-up report #2 inadvertently listed wrong serial number.Changed (b)(4).Lot #, corrected data: follow-up report #2 inadvertently listed wrong lot number.Changed 3815 to 3786.Expiration date (mo/day/yr), corrected data: follow-up report #2 inadvertently listed wrong expiration date.Changed 12/31/2017 to 09/23/2015.If explanted, give date (mo/day/yr), corrected data: follow-up report #2 inadvertently listed wrong explant date.Changed na to (b)(6) 2017.Device manufacture date (mo/day/yr), corrected data: follow-up report #2 inadvertently listed wrong manufacture date.Changed 12/06/2013 to 11/06/2013.

Event Description

The generator was received by the manufacturer.Product analysis was completed on the generator.The reports of high impedance and lead pin not fully inserted were not duplicated in the product analysis lab.No obstructions were observed in the header cavity or the connector blocks.A test lead fully inserted past the connector block.Proper lead cavity dimensions were verified.Various loads were applied and all diagnostic tests reported accurate impedance measurements.Functionality of the generator was verified in the pa lab by monitoring the generator for more than 24 hours in a simulated body temperature environment.No variations in output signal were observed and the diagnostics were as expected.There were no performance or adverse conditions found with the pulse generator.

Event Description

The patient's lead was explanted due to a second high impedance reported in mfg.Report 1644487-2017-03782, which was kept separate from this report, mfg.Report 1644487-2017-03264, as the initial reported high impedance resolved with generator replacement.Product analysis was completed on the returned lead.The allegation of high impedance was not confirmed in the product analysis lab.A set of set-screw marks were observed near the end of the lead pin indicating that the lead pin was not fully inserted at one point.Additional set-screw marks revealed that a good connection was present at one point.A more detailed account of the product analysis is summarized in mfg.Report 1644487-2017-03782.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• 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: 6358453
• MDR Text Key: 68362913
• Report Number: 1644487-2017-03264
• 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,Followup,Followup,Followup
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/23/2015
• Device Model Number: 105
• Device Lot Number: 3786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2013
• 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: 16 YR