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

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260); Mechanical Problem (1384)

Patient Problem Hypoesthesia (2352)

Event Date 01/04/2018

Event Type  malfunction  

Event Description

It was reported that the patient was experiencing a tingling sensation at the electrodes that traveled from her ear to her head.Diagnostics were performed after the tingling started, and high impedance was present.The patient used the magnet to disable the device, and she planned on asking her physician to program it off.No surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

The patient had full revision surgery due to high impedance.The generator and lead were received, but analysis has not been approved to date.No further relevant information has been received to date.

Event Description

Analysis on the lead was approved.Note that a small portion of the lead assembly including the electrodes was not returned for analysis, and therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis of the returned portion of the lead, one of the quadfilar coils appeared to be broken close to the end of the abraded open / cut outer silicone tubing.Scanning electron microscopy was performed and identified the area on three of the broken coil strands as being mechanically damaged, which prevented identification of the coil fracture type with fine pitting and residual material on one, fine pitting on another, and no pitting and residual material on the third one.The area on the remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting.Pitting was observed on the coil surface.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes.With the exception of the observed discontinuity and abraded openings observed on the outer and inner silicone tubes, the condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed, and no other discontinuities were identified.Analysis on the generator was also approved.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrated 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 successfully verified.In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.No further 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: 7262565
• MDR Text Key: 99927263
• Report Number: 1644487-2018-00196
• 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: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2018

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: 01/24/2009
• Device Model Number: 302-20
• Device Lot Number: 1547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 02/11/2018
• Supplement Dates Manufacturer Received: 05/15/2018; 06/19/2018
• Supplement Dates FDA Received: 06/06/2018; 06/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2006
• 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): Other
• Patient Age: 56 YR