MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 303

Model Number 303-20

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

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

Event Date 11/14/2018

Event Type  malfunction  

Event Description

It was reported that the patient's device has depleted and also has high lead impedance.No known adverse events were reported.Patient underwent prophylactic generator replacement and lead revision due to high impedance.The generator and lead were received.Analysis is underway but has not been completed to date.

Event Description

Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.The pulse generator diagnostics were as expected for the programmed parameters.There were no performance or any other type of adverse conditions found with the pulse generator.An analysis was performed on the returned lead portion and the reported allegations were not confirmed.A large portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.What appeared to be white deposits were observed in various locations.Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the bilumen tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.Based on the findings in the lab, there is no evidence to suggest discontinuities in the returned portion of the device.

• Brand Name: LEAD MODEL 303
• 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: 8149395
• MDR Text Key: 129979436
• Report Number: 1644487-2018-02264
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750115
• UDI-Public: 05425025750115
• 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: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/06/2011
• Device Model Number: 303-20
• Device Lot Number: 200941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2008
• 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 Age: 16 YR