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

Model Number 302-20

Device Problems High impedance (1291); Improper or Incorrect Procedure or Method (2017)

Patient Problem Seizures (2063)

Event Date 04/16/2013

Event Type  malfunction  

Manufacturer Narrative

The initial report inadvertently indicated that an adverse event was associated with this report.The initial report inadvertently indicated that an adverse event occurred which ¿required intervention to prevent permanent impairment/damage.¿.

Event Description

It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value ¿ 5539 ohms).The device was not programmed off following the high impedance observation.Seizures were observed on (b)(6) 2014.X-rays were not taken.The nurse reported that the last known diagnostic results showing lead impedance within normal limits were from (b)(6) 2012.Clinic notes were received indicating that the patient was seen by the neurologist on (b)(6) 2014 because he recently had two seizures in the same day a week prior to the office visit.The patient¿s device was tested during the office visit and diagnostic results revealed high lead impedance (impedance value ¿ 7222 ohms).Normal mode output current and magnet output current were increased.The patient denied skipping any medication doses.The notes also indicate that during an office visit on (b)(6) 2013, the patient¿s device was tested and interrogation results showed high lead impedance (impedance value ¿ 7222 ohms).

Manufacturer Narrative

Device manufacturing records were reviewed.Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.Device failure is suspected, but did not cause or contribute to a death.

Event Description

It was reported that the patient's device was replaced due to battery depletion and had normal impedance afterwards.The patient's current surgeon and neurosurgeon did not have any record of high impedance while the patient was under their care.The patient's previous neurologist did not have any record of the patient.No additional information has been received to date.

Manufacturer Narrative

Describe event or problem, corrected data: information that the explanted generator was discarded was inadvertently omitted in supplemental mdr 1.

Event Description

It was reported that the explanted generator was discarded.

• 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: 3746105
• MDR Text Key: 16939944
• Report Number: 1644487-2014-00966
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/30/2019

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: 09/30/2005
• Device Model Number: 302-20
• Device Lot Number: 009273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/25/2014
• Initial Date FDA Received: 04/11/2014
• Supplement Dates Manufacturer Received: Not provided; 11/12/2019; 12/30/2019
• Supplement Dates FDA Received: 05/05/2014; 12/06/2019; 12/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2003
• 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: 66 YR