MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 09/17/2019

Event Type  Injury  

Event Description

It was reported that the patient's generator has migrated below the left breast and the doctor believes it has moved from the original pocket.X-rays were performed on the patient however the device could not be seen.No explant has been reported to have occurred.Information was received regarding the planned generator revision for the patient.The notes stated the ct scan could not find the generator.Leads were able to be visualized.No surgical intervention has been reported to date.No additional relevant information has been received to date.

Event Description

Information was received that the patient underwent a full revision.The generator could not be found in the patient's body during surgery and as a result could not be interrogated or explanted.Electrodes could be seen in x-ray however no generator was seen.Surgeon confirmed that there is "no generator in the body" and the leads were cut, however it was previously identified that the generator was in the armpit area prior to surgery.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• 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: 9421319
• MDR Text Key: 169811082
• Report Number: 1644487-2019-02343
• 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
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/14/2011
• Device Model Number: 103
• Device Lot Number: 201216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/06/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 43 YR