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

Model Number 303-20

Device Problem Low impedance (2285)

Patient Problems Seizures (2063); No Code Available (3191)

Event Date 09/20/2017

Event Type  malfunction  

Event Description

It was reported that a patient¿s generator showed a low impedance message, upon interrogation.Clinic notes from a visit on (b)(6) 2017 were received for a referral that indicate the device has an issue and has since been turned off.The notes detail that the patient has been having an increase in ¿spells¿, clarified by the physician as partial seizures.Follow-up from the surgeon provided the low impedance was still present on the device.Additional relevant information has not been received to-date.No known surgery has occurred to-date.

Event Description

Revision surgery occurred on (b)(6) 2017.During the surgery the physician found the lead to be severely twisted into a coiled knot.The generator pocket was then dissected and it was discovered that the generator¿s stitch was broken and the twisting of the lead had continued all the way down to the generator.The physician stated the patient had manually rolled the generator from the exterior, breaking the stitch and continued to manipulate and roll the generator within the pocket until the lead became severely twisted.The severe twisting caused the impedance issue, and when the surgeon removed and untwisted the lead, the impedance issue was corrected.The surgeon installed the same generator, repositioned the same lead, stitched two tie downs of the lead in the neck, re-stitched the generator, and stitched a tie down of the lead in the pocket.Three diagnostic tests returned with impedance within normal limits.

Manufacturer Narrative

Unique identifier (udi) #, corrected data: the unique identifier was inadvertently provided incorrectly on the initial report.

Manufacturer Narrative

Unique identifier (udi) #, corrected data: the unique identifier was inadvertently provided incorrectly on follow-up report #2.

• 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: 6950569
• MDR Text Key: 90237146
• Report Number: 1644487-2017-04605
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/18/2020
• Device Model Number: 303-20
• Device Lot Number: 5064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 63 YR