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

Model Number 106

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Tissue Damage (2104)

Event Date 12/19/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that vns patient who recently had a device replacement due to eos, went abroad on holiday but a medical visit was needed when the vns wire broke through the skin at the site of the new generator.It was reported that the patient then had to have the vns system removed and was treated with antibiotics.It was reported that the patient will be reviewed once the infection has settled, with a view to a new vns system implanted.It was reported that the lead was not fully removed; the explanted generator was discarded so is not available for return.Additional information was received that cultures were taken but no growth cultured.The wound was opened showing the lead.The medical professional believes this is infection as pus was present.No known trauma or manipulation, no known medication or diet changes preceding the event.Review of manufacturing records confirmed sterilization with hp for the generator and the lead prior to distribution.

Manufacturer Narrative

The previously submitted mdr inadvertently provided the wrong date of birth for the patient.The previously submitted mdr inadvertently provided and incomplete conclusion code for the event.

Event Description

Additional information was received that patient underwent vns system re implant on (b)(6) 2016 following the full vns system removal on (b)(6) 2016 due to infection on generator site and lead accidentally cut during generator removal.

• 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: 5513581
• MDR Text Key: 40774403
• Report Number: 1644487-2016-00599
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/24/2016

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: 10/28/2016
• Device Model Number: 106
• Device Lot Number: 203167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/24/2016
• Initial Date FDA Received: 03/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2016
• 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: 60 YR