MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)

Patient Problem Seizures (2063)

Event Date 08/25/2008

Event Type  Injury  

Event Description

A report was received that a patient has been referred for replacement due to battery depletion.Further information revealed the patient also had an increase in seizures the generator has been explanted and replaced.The explanted generator has been received by the manufacturer for product analysis.Analysis is underway but has not been completed to date.No other relevant information has been received to date.

Event Description

Analysis was approved for a generator replaced due to battery depletion, and the patient experiencing increased seizures.Upon receipt, the device was operating on low battery voltage and the elective replacement indicator (eri) flag was set.An open can measurement of the battery voltage confirmed that the eri flag had been properly set; confirming that the battery was ¿depleted¿.The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Although the battery was depleted, monitoring results showed minor variations in the pulse generator¿s output signal and demonstrated that the device provided an expected level of output current for the monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the pulse generator did not perform according to functional specifications.Both of the backup capacitor¿s to can measurements did not meet specification due to an open condition for the positive backup capacitors.Additionally, the positive backup capacitor anomaly affected the waveshape pulse overshoot measurement.After the positive backup capacitor was bridged device performed according to functional specifications.Visual analysis of the feed thru capacitors showed separation of the silver polyimide to the feed-thru wire connection causing "a considered open positive backup capacitor condition.¿ it is suspected that the positive backup capacitor was not electrically attached to the feedthru wire.Other than the noted open emi capacitor, there were no other performance or any other type of adverse conditions found with the pulse generator.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• 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: 8704948
• MDR Text Key: 148200496
• Report Number: 1644487-2019-01160
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/08/2010
• Device Model Number: 102
• Device Lot Number: 200900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Event Location: Other
• Date Manufacturer Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2008
• 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: 52 YR