MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 06/10/2004

Event Type  Injury  

Event Description

It was reported that the patient's vns was explanted due to an infection at the generator site.The physician said that the patient was certain that the generator was explanted but unsure about the lead.The physician stated that the patient was currently interested in having another device implanted.Clinic notes were received and stated that vns was placed in 2004 but this had to be taken out just a few months later because he developed a staph infection.Follow-up with the physician showed that it was possibly due to vns implant surgery.No additional or relevant information has been received to date.

Manufacturer Narrative

Corrected data, initial mdr inadvertently omitted information known prior to submission of the report.

Event Description

The design history record was reviewed for the generator and lead.Both the generator and the lead were confirmed to have been eo sterilized prior to distribution.

Event Description

The patient's lead was also explanted.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7856672
• MDR Text Key: 119568380
• Report Number: 1644487-2018-01577
• 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: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/02/2005
• Device Model Number: 102
• Device Lot Number: 009771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2004
• 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 Outcome(s): Required Intervention
• Patient Age: 33 YR