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

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260); Mechanical Problem (1384); Insufficient Information (3190)

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

Event Date 01/01/2007

Event Type  malfunction  

Event Description

It was reported from the patient that the patient had an ultrasound of her breast and the her device was observed to be broken.The device has reportedly been disabled for several years due to end of service.No additional or relevant information clarifying this event has been provided to date.

Event Description

Product analysis for the generator was completed and approved.An open can measurement of the battery voltage confirmed that the battery was ¿depleted¿.The low battery voltage condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation.The device performed according to functional specifications.Product analysis for the lead was completed and approved.Abraded openings were noted on the outer and the inner silicone tubing of the lead coils.A coil break was identified in the positive and the negative lead coils at the end of the returned lead portion.Scanning electron microscopy of the lead coils show that a stress-induced fracture (due to rotational) forces has occurred in at least three strands of the quadfilar coils.Also, scanning electrode microscopy images of the lead coils show that pitting or electro-etching conditions have occurred on the positive coil.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing.No obvious point of entrance was noted other than the cut end of the returned lead portion.

Event Description

The explanted devices were received for analysis.Product analysis is currently underway.

Event Description

It was reported that the patient was having her generator explanted but the reason was unknown.It was later reported by office of the physician to be a full system explant and lead fracture had occurred for patient due to reported lack of efficacy.Per doctor's notes patient had not been using the generator for about 10 years and the lead was broken.The lead and generator were explanted.Device history record was reviewed for the lead.The lead passed all specifications prior to distribution.The explanted devices have not been received to date.No additional information has been received to date.

Event Description

During a conversation with the physician's office it was indicated that the patient's device has been broken since 2007.No other 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6853313
• MDR Text Key: 85579902
• Report Number: 1644487-2017-04432
• 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,Followup,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2008
• Device Model Number: 302-20
• Device Lot Number: 1354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 09/08/2017
• Supplement Dates Manufacturer Received: 11/01/2019; 11/18/2019; 12/18/2019; 01/14/2020
• Supplement Dates FDA Received: 11/17/2019; 12/12/2019; 01/09/2020; 02/03/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2005
• 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: 48 YR