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

Model Number 103

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

Patient Problems Pain (1994); No Code Available (3191)

Event Date 07/16/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary because the reported event has been determined as not related to the vns generator.

Event Description

It was reported by the patient that their generator had migrated into her armpit.The patient was experiencing adverse events related to the generator migration such as pain around her collarbone and ribs.The patient also reported that she had lost a bit of weight.The patient was referred for surgery.No known surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

It was reported by the physician that the patient underwent repositioning surgery due to their generator migration.The physician indicated that the surgery was due to "significant discomfort" the patient was experiencing related to the generator migration.It was also reported that the patient's generator migration caused the patient's electrode stay (tie-down) to migrate to the clavicle and cause tenderness.No further 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8095773
• MDR Text Key: 128078415
• Report Number: 1644487-2018-02135
• Device Sequence Number: 1
• Product Code: MUZ
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

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: 04/22/2016
• Device Model Number: 103
• Device Lot Number: 203064
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/21/2018
• Supplement Dates Manufacturer Received: 12/04/2018
• Supplement Dates FDA Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2014
• 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: 34 YR