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

Model Number	302-30
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Pain (1994); Seizures (2063); No Code Available (3191)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the neurologist that the patient had a fall where they hit their husband's shoulder with her vns generator.It was reported that the patient's generator became dislodged.The patient experienced immediate chest pain and less severe pain in her left neck.It was stated that vns was malfunctioning.The patient generator showed high impedance of >10000 ohms.Xrays were taken to evaluate for a lead fracture.It was stated that xrays were performed and no lead fractures were observed.It was reported that patient had battery replacement occur.It was reported that the patient did not have their lead replaced.When patient woke up, the patient was no longer feeling the pain.No additional relevant information has been received to date.
Event or Problem Description
Clinic notes for the patient were received and reviewed in which it was noted that even after the battery replacement, the impedance was seen to be within normal limits; however, is now being seen again with low output current delivered.The patient had developed high impedance after sustaining an injury last year.The patient reported that they are unable to feel their magnet stimulation when they swipe it.Information was also received that the patient is having an increasing in seizures.The patient was taken back to surgery and lead was replaced.The explanted lead was discarded by the hospital, therefore not available for product return.Generator analysis was performed on the returned generator that was explanted initially.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified.The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.Generator output was monitored and no signs of variation in the output signal were observed.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• Common Device Name: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10235602
• Report Number: 1644487-2020-00903
• Device Sequence Number: 584386
• Product Code: LYJ
• UDI-Device Identifier: 05425025750108
• UDI-Public: 05425025750108
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2013
• Device Model Number: 302-30
• Device Lot Number: 201124
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR