MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Unspecified Infection (1930); Pocket Erosion (2013)

Event Date 01/01/2015

Event Type  Injury  

Event Description

It was reported on (b)(4) 2015 that a patient¿s device was explanted on (b)(6) 2015 due to infection and erosion.There was nothing suspected to be wrong with the device, just that it had eroded through the skin.The lead and generator were received for analysis on 02/02/2015.Product analysis for the lead 302-20 was completed and approved on 02/19/2015.A portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted except for the one and a half sets of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time.Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Product analysis for the generator is underway but has not been completed to date.Attempts for additional information have been made and have been unsuccessful to date.

Event Description

Product analysis for the patient¿s m105 device was completed and approved on (b)(4) 2015.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, 3.013 volts as measured during completion of test parameter of the final electrical test, shows an ifi=no condition.There were no performance or any other type of adverse conditions found with the pulse generator.Attempts have been made for further information but have been unsuccessful to date.

Event Description

It was clarified from the physician that the skin erosion was not a lead issue but skin eroded over the generator with breakdown along the incision line.There was no gross sign of infection although clear contamination was present.The culture taken was positive for propionibacter although it was unable to tell if this was infection or contamination from adjacent skin.Therefore, primary infection was not suspected but contamination/infection after skin erosion may be more likely situation.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4542162
• MDR Text Key: 5541430
• Report Number: 1644487-2015-03963
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2016
• Device Model Number: 105
• Device Lot Number: 203087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2014
• 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: 58 YR