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

Model Number 103

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problems Itching Sensation (1943); Complaint, Ill-Defined (2331); Weight Changes (2607)

Event Date 01/01/2015

Event Type  Injury  

Event Description

On 07/12/2016, it was reported that a patient had undergone significant weight loss.This weight loss expanded the pocket where the generator rested allowing it to migrate.In clinic notes, the physician stated the pocket was very superficial with a significant amount of movement.This movement bothered the patient who also had autism to a point where the patient would itch and scratch at the incision site to the point of nearly opening the scar.The physician also noted that all diagnostics were normal without providing the specific results.The physician elected to surgically resize the pocket due to the risk of damage to the generator since the patient twiddled with the device.Revision surgery occurred on (b)(6) 2016.During this time, the patient's generator was prophylactically replaced do avoid the risk of possible damage to the device based on patient behavior.The generator is not expected to be returned since no allegations were made against the function of the device and the diagnostics were reported to be within normal limits.No further additional relevant information has been received to date.

Manufacturer Narrative

Corrected data: initial mdr inadvertently omitted information known prior to submission of the mdr.

• Brand Name: PULSE GEN MODEL 103
• 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: 5850397
• MDR Text Key: 51264858
• Report Number: 1644487-2016-01727
• 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: 07/12/2016

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: 12/31/2013
• Device Model Number: 103
• Device Lot Number: 3227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/12/2016
• Initial Date FDA Received: 08/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 21 YR