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

Model Number 103

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); No Information (3190)

Event Date 05/28/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient was scheduled for generator repositioning surgery due to an awkward position of the generator.It was confirmed that the generator had not migrated, but the awkward positioning was from the implant surgery.Attempts for further information were unsuccessful to date.

Event Description

The patient decided in pre-op on (b)(6) 2016 that she did not want to have surgery because she thought she was getting a new generator, but the physician explained that it would only be pocket revision surgery.The patient then reported that the current generator was no longer bothering her, and no surgery occurred.No further relevant information has been received to date.

Event Description

The patient had generator repositioning surgery to place the generator deeper in the pocket, because the patient was complaining of discomfort.No further relevant information has been received to date.

• 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: 5543473
• MDR Text Key: 41721088
• Report Number: 1644487-2016-00695
• 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,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2017

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: 08/08/2016
• Device Model Number: 103
• Device Lot Number: 4037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 04/03/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/11/2016; 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2014
• 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: 41 YR