MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260); Mechanical Problem (1384); Device Contamination with Body Fluid (2317); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Depression (2361); No Code Available (3191)

Event Type  malfunction  

Event Description

A patient reported that she was experiencing worsening depression and suicidal ideations.The patient's vns system was implanted in 2007 and had reportedly been helpful in managing her depression in the past.It was believed that the generator battery was dead, resulting in the worsening symptoms; however, the manufacturer's battery life calculation did not support a depleted battery, and recent device settings and diagnostics have not been received by the manufacturer to date.The patient was referred for generator replacement surgery, but surgery has not occurred to date.No additional relevant information has been received to date.

Event Description

The explanted generator and lead were received by the manufacturer for product analysis.Product analysis was completed on the returned generator.As received, the generator was at end of service condition due to normal expected battery depletion per the electrical performance of the generator.Per functional and electrical tests, the generator performed as expected with no anomalies identified.Product analysis was performed on the lead, which was returned in two portions.Good setscrew marks were found on the returned connector pin, which provided evidence that at one point in time a good mechanical and electrical connection was present.There were observed abrasions and the quadfilar coils appeared to be stretched, spiraled, kinked and extended due to wear and manipulation of the lead during the explant procedure.There were two coil breaks identified.One scanning electron microscopy identified that the broken coil strands had evidence of a stress induced fracture, fatigue appearance, with damage and fine pitting.The other coil break identified mechanical damage and no pitting.The lead assembly additionally had dried remnants of what appeared to have once been body fluids inside the outer tubing and two abraded openings were identified.Note that a large portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.With the exception of the observed discontinuities the condition of the returned lead portions are consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.No further relevant information has been received to date.

Event Description

The patient underwent surgery.The existing generator could not be interrogated preoperatively.Once the generator was replaced with another, high lead impedance was identified.The surgeon confirmed that the lead pin had been fully inserted into the generator header and secured adequately.Lead pin reinsertion troubleshooting was performed, but the high impedance measurement persisted.The patient's neck incision site was opened to access the lead and revealed a severed lead, prompting the physician to also replace the lead.It is unclear if the high impedance contributed to the patient's worsening depression and suicidal ideations.The explanted lead and generator have not been received by the manufacturer to date.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7573873
• MDR Text Key: 110237313
• Report Number: 1644487-2018-00967
• Device Sequence Number: 1
• Product Code: MUZ
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2009
• Device Model Number: 302-20
• Device Lot Number: 200395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 06/18/2018; 03/22/2019
• Supplement Dates FDA Received: 07/13/2018; 04/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2006
• 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: 62 YR