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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problems Dyspnea (1816); Numbness (2415); Neck Pain (2433)

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

Patient problem :3191; patient problem :1994; patient problem :3191; patient problem :2352; patient problem :2607; patient problem :1880; patient problem :1980.

Event Description

It was reported that a patient feels erratic stimulation and has a dcdc code indicating high impedance.The patient's pulse width was decreased in response.It was then reported that the patient was being referred for replacement due to low battery and "all the other stuff going on with the device".This is referring to the patient's reported adverse events of erratic stimulation and trouble breathing and talking when the device goes off.The physician reported that the dcdc code had been fluctuating.Additional adverse events were reported to be fluctuating and noted to be numbness in neck, ear pain, sinus pain, jaw pain, headaches, tingling, voice hoarseness, weight loss and heart issues.It was stated that when the patient disabled her device with the magnet, she reported having tingling, voice hoarseness, and a bit of headaches, but that all other symptoms mostly subside when the device is disabled.The patient stated that the breathing issues now are different than the ones from the past and that the patient has trouble catching her breath now and not just difficulty breathing.Further information was received that on a subsequent system diagnostic test with the patient's head facing forward and turned to the right, the patient has impedance within normal limits.Information was received that the patient's generator was replaced due to battery depletion and their lead was also replaced.The patient's lead has not been received by livanova to date.No additional relevant information has been received to date.

Manufacturer Narrative

Relevant tests/laboratory data, including dates: corrected data; supplemental #1 mdr inadvertently submitted incorrect data.

Event Description

Generator analysis approved and reviewed.The reported end of service (eos) allegation was not confirmed in product analysis (pa) lab.During analysis there was no indication that the device was at an eos condition.The generator device output signal was monitored for more than 24-hours while the generator was placed in a simulated body temperature environment.The results showed no signs of variation in the generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.A battery life calculation (blc) resulted in 2.10 years remaining before the elective replacement indicator (eri) flag would be set.The pa worksheet, blc, and programming history database (phd) were reviewed and no anomalies were found.The generator diagnostics were expected for the provided parameters.The device performed according to functional specifications and there were no abnormal performance or any other adverse condition found.Pa was able to confirm proper functionality of the generator lead analysis was also reviewed.The lead was returned due to high impedance and the patient receiving erratic stimulation as a result.Both the small boot o-ring and the large boot o-ring have partial detachment from the connector ring, however no obvious adverse effect was identified on the device performance as a result of the condition.The reported high impedance was not verified within the returned lead portion.Except for the partial detachment of both the small o-ring and large o-ring boot from the connector ring, there were no other issues with the returned lead portions.Per the images attached, the lead was wavy in appearance within the silicone tubing.Abrasions were noted on the outer silicone tubing at multiple locations.The outer silicone tubing has a compressed appearance at multiple locations.The outer silicone tubing has what appear to be internal abrasions at multiple locations.Information was received that per the physician the reported side effects of pain under lead in neck, numbness in neck, ear pain, sinus pain, jaw pain, tingling, hoarseness, weight loss, and heart issues were all unrelated to the vns.No additional relevant information has been received to date.

Event Description

Information was received from the physician regarding the patient's condition.It was stated that the device was "just acting weird and that it was really scary for the patient".It was reported that the patient had started to have heart palpations, her face felt numb "like she was coming off of novocaine", she had pain in her head, and her breathing changes were different, as the patient was breathing faster.The physician stated that these events were related to the stimulation/vns.The patient usually feels stimulation normally and felt it differently now and believed something was wrong.The patient was seen in (b)(6) and the pulse width was lowered.At the end of (b)(6), the device was checked and was seen to have a high dcdc code, however it is unknown whether this was seen on a normal mode or system diagnostic.When checked again in (b)(6), the patient no longer had this high dcdc code and the impedance when checked on a system diagnostic test was within normal limits.At this time, the patient was experiencing shortness of breath when the device geos off, voice changes, does not talk normally, and the patient at this time was wearing the magnet a lot.It was stated the patient came into the clinic at the end of september reporting a "scary episode where her heart was fluttering, and she had pain in her face and sinus".The physician stated they turned off the device at this time and was referred for replacement surgery.X-rays were also reviewed at this time and no anomalies were found.The patient's explanted products have been received however analysis has not been completed 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: 9173459
• MDR Text Key: 161834234
• Report Number: 1644487-2019-01960
• 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: 11/21/2019

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: 11/01/2006
• Device Model Number: 302-20
• Device Lot Number: 011406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 10/09/2019
• Supplement Dates Manufacturer Received: 10/10/2019; 10/31/2019
• Supplement Dates FDA Received: 10/30/2019; 11/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2004
• 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: 42 YR