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

Model Number 302-20

Device Problem High impedance (1291)

Patient Problem Seizures (2063)

Event Date 10/25/2019

Event Type  malfunction  

Event Description

It was reported that a patient's generator was interrogated and high impedance was detected.The patient also had a seizure after previously being well controlled.The patient was referred for surgery.No surgical intervention has occurred to date.No additional information has been received to date.

Event Description

Suspect lead product analysis was completed and approved.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.Since a portion of the lead assembly was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Explanted generator product analysis was completed and approved as well.An electrical evaluation showed that the device performed according to functional specifications.The battery showed an ifi=no condition.No additional information has been received to date.

Event Description

It was reported that the patient had a full revision.It was reported that during the revision, a new lead was implanted and tested with the previous generator.The previous generator tested with high impedance at this point, even after system diagnostics were performed and pin reinsertion was attempted.Once a new generator was connected to the new lead, the impedance was within normal limits.The generator and a piece of the lead were received for product analysis.Product analysis of the generator and lead has not been completed and approved to date.The high impedance that occurred when the previous generator was connected to the new lead is captured in mfr report #1644487-2020-00155.The high impedance that occurred before the lead revision is captured in this report.No additional relevant information has been received to date.

Manufacturer Narrative

Device evaluated by mfr?, data correction: selection of "yes" was inadvertently omitted in supplemental report #2.

• 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: 9532016
• MDR Text Key: 183503758
• Report Number: 1644487-2019-02524
• 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,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/13/2006
• Device Model Number: 302-20
• Device Lot Number: 011040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2004
• 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: 26 YR