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

Model Number 302-20

Device Problem Fracture (1260)

Patient Problems Dyspnea (1816); Pain (1994); Seizures (2063)

Event Date 09/10/2018

Event Type  malfunction  

Event Description

It was reported that upon interrogation this patient's device was showing near end of services (neos) = yes and high impedance.The patient has been referred for surgery.Clinic notes were received for this patient's replacement due to high impedance which indicated that the patient is showing decreased battery life and abnormal lead impedance as well as recurrent seizures.The patient reports electrical pain with head turning left.And therefore the vns was reprogramed to reduce pulse width.The patient also feels shortness of breath intermittently every couple days with the vns going off.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

Explant date, corrected data: supplemental report #1 inadvertently listed a date for the explant date.The suspect device was not explanted at that time.

Manufacturer Narrative

Adverse event or product problem, corrected data: initial report inadvertently did not list adverse event.Outcomes attributed to adverse event, corrected data: initial report inadvertently did not check "required intervention to prevent permanent impairment/damage".

Event Description

It was reported that this patient received a generator replacement.The lead impedance was ok at the time of surgery when the generator was replaced.The explant facility was stated to be a no return site per the or staff.No other 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7933577
• MDR Text Key: 122633593
• Report Number: 1644487-2018-01757
• 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
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/24/2009
• Device Model Number: 302-20
• Device Lot Number: 1547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2006
• 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: 24 YR