MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Skin Erosion (2075)

Event Date 11/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient had their device eroding through the skin.The patient's device was implanted in (b)(6) and the device was reportedly seen through the skin.The patient's device was explanted due to the extrusion.The device was sent to the manufacturer for analysis.The patient did not undergo replacement at the time to allow the wound to heal before implanting a new device.The patient's surgeon did not state that the extrusion was related to an infection.The device history record for the implanted generator was reviewed and it was verified to pass all functional specifications and was sterilized per specifications.The device is currently undergoing analysis by the manufacturer.

Manufacturer Narrative

(b)(4).

Event Description

The returned generator had product analysis (pa) completed.Per the pa results, the generator performed according to all functional specifications and was able to accurately measure impedance values.A review of the generator data showed that impedance values within normal limits were present right before device explant.No anomalies were identified with the returned generator.

• Brand Name: PULSE GEN MODEL 106
• 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: 6135991
• MDR Text Key: 61154184
• Report Number: 1644487-2016-02753
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/17/2017
• Device Model Number: 106
• Device Lot Number: 203437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2016
• 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: 7 YR