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

Model Number 106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient had a collection of fluid and bruising around the generator site.The physician denied any trauma had occurred that could have contributed to the bruising and fluid collection.The patient underwent exploratory surgery where it was observed that the generator pocket was infected.The generator was explanted at that time and the lead was left implanted.The generator had been implanted for several months prior to the infection being found and it was not known why the infection presented so long after surgery.The manufacturing record of the generator was reviewed and it was observed that the generator was sterilized prior to distribution.No additional relevant information has been received to date.

Event Description

The explanted generator was received and is currently pending product analysis.

Manufacturer Narrative

(b)(4).

Event Description

Product analysis was completed on the explanted generator.During analysis it was found that the generator performed to functional specifications and no anomalies were observed.

Event Description

It was reported that the infection had resolved.

• 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: 6025039
• MDR Text Key: 57250123
• Report Number: 1644487-2016-02346
• 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,Followup,Followup,Followup
• Report Date: 10/09/2017

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: 10/08/2017
• Device Model Number: 106
• Device Lot Number: 203558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 09/14/2017
• Supplement Dates FDA Received: 11/07/2016; 12/01/2016; 01/05/2017; 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2015
• 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: 50 YR