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

Device Problem Low impedance (2285)

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

Event Date 02/26/2019

Event Type  malfunction  

Event Description

It was reported that the patient's device showed low impedance during their last diagnostic test.A review of the device history records indicated that the patient's generator passed all functional specifications prior to distribution.No known relevant surgical intervention has occurred to date.Attempts were made to the neurologist to obtain additionally information regarding the low impedance.No further relevant information has been received to date.

Event Description

Additional information was received confirming that the generator battery is at 75%-100%.The lead impedance is noted to still be within normal limits.At this time, the generator is functioning as expected and battery is depleting as expected.No other relevant information has been received to date.

Event Description

It was reported by the physician that the patient had low battery and not low impedance as previously reported.No further relevant information has been received to date.

• Brand Name: LEAD MODEL UNKNOWN
• 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: 8442318
• MDR Text Key: 139542026
• Report Number: 1644487-2019-00560
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 46 YR