MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

Model Number 304-20

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 07/18/2018

Event Type  malfunction  

Event Description

It was reported that during a patient¿s prophylactic generator replacement, the lead wires were found to be exposed after the chest site was opened.All pre-surgical diagnostics and diagnostics at the neurologist follow up two weeks prior showed normal impedance readings.The lead and generator were replaced.Additional relevant information has not been received to-date.The explanted devices have not been received by the manufacturer to-date.

Manufacturer Narrative

Event description, corrected data: information was inadvertently provided incorrectly in the initial report.Device evaluated by mfr, corrected data: the device evaluation field was inadvertently marked incorrectly on the initial report.Evaluation codes, corrected data: a conclusion code was inadvertently not provided on the initial report.

Event Description

The reason for replacement was provided to be prophylactic for the generator and due to a discontinuity with the lead.The explanted devices were received.Analysis is underway, but has not been completed to-date.

Event Description

Analysis was completed for the returned generator.The pulse generator diagnostics were as expected for the programmed parameters.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.Electrical evaluation showed that the generator performed according to functional specifications.The battery measured 2.829 volts and was not in a depleted condition.The downloaded data revealed that 77.136% of the battery had been consumed.There were no performance or any other type of adverse conditions found with the pulse generator.Analysis was completed for the returned lead.The reported lead break was not verified within the returned lead portions.Fluid leaks were verified.Abraded openings were noted on the outer silicone tubing at multiple locations.Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

• Brand Name: LEAD MODEL 304
• 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: 7773202
• MDR Text Key: 116865144
• Report Number: 1644487-2018-01367
• 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,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2016
• Device Model Number: 304-20
• Device Lot Number: 202003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/24/2012
• 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: 44 YR