MAUDE Adverse Event Report: LIVANOVA USA, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problem Fracture (1260)

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

Event Date 01/16/2019

Event Type  malfunction  

Event Description

The physician reported that the patient had experienced a lead fracture and their generator had migrated to the right side of their chest.It was stated that the patient¿s lead and generator were explanted.It was later discovered during follow up with the sales representative present at surgery that the patient also had an infection.Generator migration and infection events have been reported in mfg report # 1644487-2019-00243.Further follow up with surgeon confirmed that lead fracture was determined via x-ray, and that the believed cause of the lead fracture was due to generator migration.The surgeon mentioned that they do not know reason for generator migration due to patient being lost to follow up.However, it was noted that the generator was previously secured with absorbable sutures (o-vicryl).The surgeon also mentioned that the infection occurred at generator site due to skin breakdown.No other relevant information is known at this point in time.It was stated that the lead was discarded after surgery.

Event Description

Product analysis has been completed for both the generator and lead.A majority of the lead was not returned for analysis, and therefore, an evaluation and resulting commentary cannot be made on that portion of the lead.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.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.Additionally, continuity checks of the returned lead portions were performed and confirmed no discontinuities.Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions.The generator was explanted and returned due to a low battery status unknown.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.An open can measurement of the battery voltage confirmed that the battery was depleted.The low battery voltage condition was concluded to be the result of normal, expected battery depletion.There were no performance or any other type of adverse conditions found with the pulse generator.No other relevant information has been received to date.

Manufacturer Narrative

Date of event, corrected data: initial report inadvertently listed wrong event date.Device evaluation is underway.

Event Description

The explanted generator and lead have been received by the manufacturer.Product analysis is underway but has not been completed to date.No further relevant information has been received to date.

• Brand Name: BIPOL LEAD MODEL 300
• 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: 8324971
• MDR Text Key: 135711201
• Report Number: 1644487-2019-00242
• 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 Assistant
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/12/2002
• Device Model Number: 300-20
• Device Lot Number: 1862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2000
• 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: 31 YR