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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problems Seizures (2063); Neck Stiffness (2434)

Event Date 06/17/2015

Event Type  malfunction  

Event Description

During review of programming and diagnostic history, high lead impedance was found on patient vns system.The generator was switched temporarily switched off.Additional information was received that the high impedance was solved by replacing the lead.It was reported that the explanted lead did not show any visual anomalies and the lead impedance was normal after the surgery.It was reported that the explanted lead has been discarded by the hospital and will not be returned to the manufacturer for analysis.It was reported that during the seizure, patient has is neck twist and stiff neck, which may have contributed to the lead breakage.Review of manufacturing records confirmed all tests passed for the concerned lead prior to distribution.

Event Description

An article was received indicating that 10 patient's were found to have high impedance due to intrinsic lead damage.Two of these patients were able to be identified.Patient 8 was identified as being captured in this report.Patient 10 was previously reported under mfr report #1644487-2016-02308.Mfr report # 1644487-2019-00466 captures the remaining unknown patients.It was reported that this report's patient experienced an increase in seizures after high impedance was found on her device.Pin reinsertion and generator diagnostics were performed during revision surgery to confirm complete pin insertion and generator function.The high impedance was attributed to intrinsic lead damage.No further relevant information has been received to date.

Manufacturer Narrative

Describe event or problem, corrected data: the fact that the patient experienced an increase in seizure severity along with an increase in seizure frequency was inadvertently not reported in supplemental report 1 attachments, correction: the article reporting the lead failure was inadvertently not attached to supplemental report 1.

Event Description

It was reported that along with the increase in seizure rate, the patient also experienced an increase in seizure severity.

• 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: 6019914
• MDR Text Key: 57111638
• Report Number: 1644487-2016-02306
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2013
• Device Model Number: 302-20
• Device Lot Number: 201288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/16/2016
• Initial Date FDA Received: 10/12/2016
• Supplement Dates Manufacturer Received: 02/13/2019; 04/04/2019
• Supplement Dates FDA Received: 03/10/2019; 04/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2009
• 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: 46 YR