MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 09/04/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 clinic notes were received dated (b)(6) 2015 which indicate that the surgeon repositioned the patient's generator on (b)(6) 2015 and patient did well and went home and then on (b)(6) 2015 the patient felt it move lower in her chest.The surgeon noted that the incision looks good but that the generator is indeed lower in her chest than it was placed.The surgeon noted that he did tie the generator down last time to the fascia above her pectoralis muscle.Good faith attempts for further information from the physician have been made but no additional information has been received to date.

Event Description

The surgeon reported that a non-absorbable suture was used to secure the generator to the fascia during implant.The primary care physician told the surgeon that he believes the patient would intentionally manipulate her device.

Event Description

It was reported on (b)(6) 2015 that a generator revision surgery occurred on (b)(6) 2015.The patient's generator was repositioned to her back.The diagnostics following repositioning were reported to be within normal limits.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, 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: 5161451
• MDR Text Key: 28720394
• Report Number: 1644487-2015-06161
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2016
• Device Model Number: 105
• Device Lot Number: 203064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2014
• 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: 17 YR