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

Model Number 102R

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

Patient Problems Fibrosis (3167); No Code Available (3191)

Event Date 04/25/2018

Event Type  Injury  

Event Description

During a prophylactic generator replacement surgery for this patient¿s m102r to a m104, while removing the m102r, it was observed that the header of the device had become detached from the generator.It was unclear exactly when the header had become detached.The patient had a significant amount of breast tissue and the generator was beneath the nipple, so the or specialist believed that the header detachment occurred as a result of the physician trying to get the generator out of the patient's body with the clamp and due to a lot of scar tissue.It was also stated that the battery migrated far away from where it was implanted.He interrogated the m102r after explant and saw that the battery was ok, but that no current was being delivered.The surgeon stated that the battery must have not been sutured down in one of the previous 2 surgeries.There was a lot of tissue and adhesions, so the battery was hard to get to and took time.The explanted generator was received for analysis and analysis is underway but has not been completed to date.No additional or relevant information has been received to date.

Manufacturer Narrative

Describe event, corrected data, initial mdr inadvertently reported that the surgery was due to the migration while in fact the migration was discovered during surgery, while the surgery was already being performed for prophylactic reasons.

Event Description

Product analysis for the generator was completed and approved.Diagnostics testing during the implant period did not report a high impedance condition.After a window was cut into the can to attach wires and test leads to make output connections to the final test fixture, the device performed according to functional specifications of the current automated final test 102.Other than the header anomaly, there was no performance or any other type of adverse condition found with the pulse generator.The header detachment was found to be possibly explant related.During the initial report, there was no indication that the surgery was for suspected migration.The surgery was only performed prophylactically and then migration was seen during surgery.

• Brand Name: PULSE GEN MODEL 102R
• 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: 7525800
• MDR Text Key: 108636541
• Report Number: 1644487-2018-00808
• 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
• Report Date: 06/25/2018

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: 07/31/2012
• Device Model Number: 102R
• Device Lot Number: 2762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 06/14/2018
• Supplement Dates FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2010
• 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): Other
• Patient Age: 23 YR