MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Infection (1930)

Event Date 12/15/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A provider reported that a vns patient who had recently undergone prophylactic generator replacement had her generator explanted due to an infection.The patient's lead was not explanted.Follow up with the provider indicated that the infection was caused by the patient scratching open the incision site with a wire brush.Cultures taken confirmed the infection as staphylococcus epidermis.Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.The hospital does not return explanted devices per hospital policy so the devices are not expected to be returned for product analysis.The patient may be re-implanted at a future date but no known re-implantation has occurred to date.

• Brand Name: PULSE GEN MODEL 104
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5399741
• MDR Text Key: 37162544
• Report Number: 1644487-2016-00155
• 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
• Report Date: 01/06/2016

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: 09/15/2016
• Device Model Number: 104
• Device Lot Number: 4092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/06/2016
• Initial Date FDA Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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: 27 YR