MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

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

Patient Problem Pain (1994)

Event Date 01/01/2018

Event Type  Injury  

Event Description

Clinical notes were received stating that the patient was experiencing pain in the neck and that the patient was referred for replacement due to the pain.The device was subsequently replaced.The explanted product has not been received for analysis to date.No additional or relevant information has been received to date.

Event Description

Information was received that the patient was experiencing pain at the generator site that reportedly felt random.It is not clear at this time if this is related to the current report of pain, or to an event the patient experienced several years ago that required admission for pain control (reported on mfr report # 1644487-2018-00680).It appears that revision surgery (reported on the initial report) was also taken due to the pain at the generator site.The device was discarded and will not be received for analysis.No additional or relevant information has been received to date.

Event Description

Information was received clarifying that the pain at the generator site, for which surgery was taken, was a current complaint and not related to an event from 2011 (which is reported on mfr report # 1644487-2018-00680).It was also clarified that the patient was experiencing a "grinding" feeling at the site of the generator, and that the surgery was taken to reposition the new generator.The patient was reported to be doing well since the surgery.No additional or relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 104
• 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: 7468315
• MDR Text Key: 106730027
• Report Number: 1644487-2018-00672
• 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
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2012
• Device Model Number: 104
• Device Lot Number: 201513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 8 YR
• Event Location: Other
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 05/01/2018; 06/18/2018
• Supplement Dates FDA Received: 05/25/2018; 07/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2010
• 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: 46 YR