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

Model Number 302-30

Device Problems Corroded (1131); Fracture (1260); High impedance (1291); Device Contamination with Body Fluid (2317)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/18/2019

Event Type  malfunction  

Event Description

Patient was referred for generator and possible lead replacement.The patient had experienced a fall had completely dislodged the patient's generator and broken the leads.High impedance was observed pre-operatively and was thought to be due to pin reinsertion.When the patient was opened for surgery, it was noted that the pin was no longer inserted in the generator.The generator was then replaced and high impedance was still observed.The surgeon proceeded with lead replacement thinking that the lead may have broken during the patient's fall.The explanted lead and generator were received by product analysis.Product analysis has not been completed to date.No other relevant information has been received to date.The reported generator migration (generator becoming dislodged) was captured in mfr.Report #1644487-2019-00378.

Event Description

Generator product analysis was completed.The product analysis lab confirmed that the generator was at normal ifi (intensified follow-up indicator)=no condition.The reported high impedance and pin not fully inserted were not duplicated in the product analysis lab.A bench in-line lead fully inserted into the pulse generator header, past the negative connector block (lab conditions).There were no performance of any other type of adverse events found with the pulse generator.Lead product analysis was completed.The lead was returned in three portions and one loose tie downs.Electrodes were not returned therefore evaluation and resulting commentary cannot be made on that portion of the lead.During the visual analysis of the returned 342mm and 55mm portions, the connector ring quadfilar coil appeared to be broken.Scanning electron microscopy was performed and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting.The area on the remaining broken coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting.Pitting was observed on the coil surface.The abraded open / cut area 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 found inside the outer and inner silicone tubing.A set of setscrew marks were seen on the marked connector pin providing evidence that proper contact between the setscrew and the marked connector pin existed at least once.Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions.

• 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: 8378306
• MDR Text Key: 137417778
• Report Number: 1644487-2019-00377
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2004
• Device Model Number: 302-30
• Device Lot Number: 6900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2002
• 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 Age: 72 YR