MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 04/12/2019

Event Type  malfunction  

Event Description

Patient referred for device explant as the patient had not used the device in a longtime.It was also noted that the generator had migrated into the patient¿s breast, wasn¿t placed properly, and was no longer in place.It was noted that the generator was under the patient¿s breast tissue.This resulted in the patient requesting the device removal.X-rays were performed and indicated that the generator was under the breast tissue.X-rays have not been received or reviewed to date.Further information was received from the physician¿s nurse that the physician¿s assessment of the migration was unknown.It was noted that the device was no longer working and had moved.It was noted that the device had not been used for some time.No further explanation of the device not working was provided.The device was confirmed to have been explanted.The explanted products have not been received to date.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8635932
• MDR Text Key: 145929451
• Report Number: 1644487-2019-01006
• 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
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/19/2007
• Device Model Number: 102
• Device Lot Number: 012890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2005
• 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 Age: 71 YR