MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problems Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979)

Patient Problem Discomfort (2330)

Event Date 01/01/2016

Event Type  Injury  

Event Description

It was reported that the patient has been having some issues with her vns generator.The generator is now reported to be moving in the chest wall and is protruding and rotating causing her significant discomfort.There was no known trauma that may have caused the device to rotate/protrude.The physician reported that this migration began >6 months ago.The patient is planned for full device explant but the explant has not occurred to date.

Event Description

Operative notes from (b)(6) 2007 were received on 08/02/2016.Notes state that the generator was inserted into the subcutaneous pocket on the left upper anterior chest and was sutured to the pectoralis fascia with a 3-0 silk suture (non-absorbable suture).No surgical intervention has occurred to date.

Event Description

Operative notes were received on 09/13/2016 for the patient's surgery on (b)(6) 2016.The patient had a full device explant on (b)(6) 2016.The reason stated was painful hardware with vns.Notes state the device was not effective for her and it became painful for her.The explanted device was discarded and will not be returned for analysis.

• Brand Name: PULSE GEN MODEL 102
• 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: 5826374
• MDR Text Key: 50564262
• Report Number: 1644487-2016-01696
• Device Sequence Number: 1
• Product Code: MUZ
• 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,Followup
• Report Date: 07/05/2016

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: 08/31/2008
• Device Model Number: 102
• Device Lot Number: 016174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/05/2016
• Initial Date FDA Received: 07/27/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/24/2016; 10/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2006
• 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: 56 YR